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I really think the financials where better than I ever seen them!
Leaders in Cell Therapy Development and Manufacturing
Caladrius Biosciences Reports 2016 Second Quarter Financial Results
Total Quarterly Revenues Increase 41% and Expenses Decrease 50% versus Prior Year
Conference Call Begins Today at 5:00 pm Eastern Time
BASKING RIDGE, N.J. (August 9, 2016) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider through its subsidiary PCT, LLC a Caladrius Company™ (“PCT”) with a select therapeutic development pipeline, announces financial results for the three and six months ended June 30, 2016.
Business highlights for the second quarter and recent weeks include:
Achieved total revenues of $8.3 million for the second quarter of 2016, up 41% compared with $5.9 million in the second quarter of 2015;
Achieved total operating costs and expenses reduction of 50% in the second quarter of 2016 when compared with the second quarter of 2015;
Granted Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for CLBS03 for the treatment of recent onset type 1 diabetes mellitus (“T1D”), making it the first known therapeutic candidate to receive Fast Track designation for treatment of T1D;
Granted Orphan Drug designation from the FDA for CLBS03 for the treatment of T1D with residual beta cell function;
Expanded PCT’s relationship with Kiadis Pharma with an agreement for the manufacturing of their lead product, ATIR101™, for the U.S. and Canadian Phase 3 trial in blood cancers;
Announced the appointment of Robert A. Preti, Ph.D., the Company’s Chief Technology Officer, Senior Vice President, Manufacturing and Technical Operations, and President of PCT, as Chairman of the Alliance for Regenerative Medicine (“ARM”), the international advocacy organization representing the gene and cell therapies and broader regenerative medicine sector; and
Licensed exclusive global rights to the Company’s tumor cell/dendritic cell technology for the treatment of ovarian cancer to AiVita Biomedical, Inc. In return, Caladrius will receive certain development milestone payments as well as royalties on sales.
Management Commentary
“We remain very pleased with our year-to-date performance as we continue to deliver on our strategic goals to grow and expand the PCT business, to reduce expenses, to advance our Phase 2 T-Rex clinical trial as a treatment for T1D and to monetize non-core assets,” stated David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We are delighted to add Fast Track and Orphan Drug designations to CLBS03 for the treatment of T1D as they underscore the significant unmet medical need in this degenerative disease, and provide regulatory provisions that can accelerate the review process and expand our market exclusivity. We look forward to completing enrollment and treatment of the first cohort of 18 patients toward the end of summer. Following the three-month post-treatment visit, an interim safety analysis will be conducted, and we expect to have these results by year-end 2016.”
“We entered the second half of 2016 in a solid position to continue advancing our strategic goals and achieving our financial guidance for the year. We are delighted that a growing number of cell therapy developers are partnering with PCT to take advantage of our expertise and our quality, scalable, innovative, reliable and cost-efficient manufacturing platforms and services to advance their cellular therapies.”
“Our leadership in regenerative and cell therapy was further solidified with the appointment of Dr. Robert Preti as Chairman of ARM. As a pioneer in cell therapy manufacturing and development, Dr. Preti remains at the forefront of the industry, influencing regulatory trends and policy making. ARM’s dedication to advancing regenerative medicine and cell therapies and to bringing its stakeholders together is unprecedented, and aligns with PCT’s vision of contributing to a world in which transformative cell-based therapeutics are accessible to all patients in need,” concluded Dr. Mazzo.
Second Quarter Financial Highlights
Total revenues for the second quarter of 2016 increased 41% to $8.3 million compared with $5.9 million for the second quarter of 2015. Gross margin on revenues was 15% in the second quarter of 2016 compared with 1% in the second quarter of 2015.
Research and development (R&D) expenses for the second quarter of 2016 decreased 47% to $4.0 million compared with $7.6 million for the second quarter of 2015. The decrease was primarily related to lower costs subsequent to the discontinuation of the Intus Phase 3 clinical trial for metastatic melanoma as well as lower program expenses associated with the Company’s ischemic repair platform, compared with the prior-year period. These decreases were partially offset by an increase in expenses related to The Sanford Project: T-Rex Phase 2 Study in T1D.
Selling, general and administrative (SG&A) expenses decreased 46% to $4.7 million for the second quarter of 2016 compared with $8.7 million for the same period in 2015. The decrease is due to both lower equity-based compensation costs and operational and compensation-related cost reductions compared to the prior year period.
The operating loss for the second quarter of 2016 was $7.5 million compared with an operating loss of $25.7 million for the second quarter of 2015, reflecting higher revenues and gross margin, and lower R&D and SG&A expenses, as well as an impairment of intangible assets in the second quarter of 2015.
The Company reported a net loss for the second quarter of 2016 of $7.9 million, or $1.33 per share, compared with a net loss for the second quarter of 2015 of $17.2 million, or $3.84 per share.
First Half Financial Highlights
Total revenues for the six months ended June 30, 2016 increased 75% to $15.8 million compared with $9.0 million for the first six months of 2015. Gross margin for the first half of 2016 was 16% compared with a negative 1% for the first half of 2015.
R&D expenses for the first half of 2016 decreased to $9.9 million compared with $14.4 million for the first half of 2015. SG&A expenses decreased to $11.2 million for the first half of 2016 compared with $19.8 million for the same period in 2015. The first half of 2015 included expenses associated with executive management changes including one-time new hire compensation-related costs. The first half of 2016 included separation-related costs incurred during the first quarter of 2016, while equity-based compensation expenses were significantly lower in the first half of 2016 compared to the prior year period.
The operating loss for the first half of 2016 was $18.6 million compared with an operating loss of $43.8 million for the first half of 2015.
The net loss for the six months ended June 30, 2016 was $19.9 million, or $3.39 per share, compared with a net loss for the six months ended June 30, 2015 of $36.4 million, or $8.83 per share.
Balance Sheet and Cash Flow Highlights
As of June 30, 2016, Caladrius had cash and cash equivalents of $17.7 million. Net cash used in operating activities for the six months ended June 30, 2016 was $14.6 million, compared with $21.8 million for the six months ended June 30, 2015.
2016 Financial Guidance
The Company reaffirms its previous guidance as follows:
Consolidated Revenues: to exceed $30 million or a greater than 30% increase compared with 2015
Capital Improvements at PCT’s Allendale, NJ facility: ~$6 million, to be completed by end of first half of 2017
CLBS03 Phase 2 Study Costs in 2016: $6 million to $7 million
Consolidated Annual Operating Cash Burn: $25 million to $28 million in 2016, with lower operating cash burn in the second half of 2016 than in the first half of the year
Conference Call
As previously announced, Caladrius management will host a conference call to discuss these 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 95709219.
To access the live webcast, visit the Investor Relations section of the Company’s website at www.caladrius.com/events. The webcast will be archived on the website for 90 days.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its PCT subsidiary, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding the realization of the benefits of fast track designation for CLB03, the achievement of clinical milestones for CLB03 and the establishment of a partnership for CLBS03. 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 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
Caladrius Biosciences, Inc. Selected Financial Data (unaudited)
Three Months Ended June 30, Six Months Ended June 30,
(in thousands, except per share data) 2016 2015 2016 2015
Statement of Operations Data:
Revenues $8,300 $5,867 $15,790 $9,039
Costs and expenses:
Cost of revenues 7,052 5,799 13,280 9,167
Research and development 4,028 7,601 9,904 14,404
Impairment of intangible assets - 9,400 - 9,400
Selling, general, and administrative 4,706 8,736 11,164 19,824
Total operating costs and expenses 15,785 31,536 34,348 52,796
Operating loss (7,485) (25,669) (18,558) (43,757)
Other income (expense), net 7 5,355 13 4,809
Interest expense (360) (547) (1,287) (1,098)
Loss before income taxes and noncontrolling interests (7,838) (20,861) (19,832) (40,046)
Provision for income taxes 47 (3,703) 100 (3,657)
Net loss (7,885) (17,158) (19,933) (36,390)
Less - loss attributable to noncontrolling interests (50) (32) (117) (76)
Net loss attributable to Caladrius Biosciences, Inc. common stockholders $(7,835) $(17,126) $(19,816) $(36,313)
Basic and diluted loss per share attributable to Caladrius Biosciences, Inc. common stockholders (1.33) (3.84) (3.39) (8.83)
Weighted average common shares outstanding 5,907 4,457 5,840 4,110
June 30, 2016 December 31, 2015
Balance Sheet Data:
Cash, cash equivalents, and marketable securities $17,700 $20,318
Total assets 56,713 57,205
Total liabilities 31,676 33,921
Total redeemable securities 19,400 -
Total equity 5,637 23,284
Past Press Releases
July 28, 2016
Caladrius Biosciences receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes
July 27, 2016
Caladrius Biosciences Announces 1-for-10 Reverse Split
June 27, 2016
Caladrius Biosciences SVP and President of PCT, Robert Preti, PhD, Named Chairman of the Alliance for Regenerative Medicine
Events
July 28, 2016
Regenerative Medicine Crossroad
July 18, 2016
CIRM Bridges Meeting
July 11, 2016
Business of Regenerative Medicine: How to Build a Company
All places now recruiting!!! https://clinicaltrials.gov/ct2/show/NCT02691247?term=Clbs03&rank=1
BASKING RIDGE, N.J., July 7, 2016 -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces today that the Company’s leadership will present at the following upcoming July conferences:
Business of Regenerative Medicine: How to Build a Company
Date and Time: Monday, July 11, 2016, 2:00 PM ET
Website: http://hsci.harvard.edu/event/brm_2016
Venue: Harvard Business School, Cambridge, Massachusetts
Topic: Building the Future: Advanced Therapies & Scalability
Presenter: Robert A. Preti, PhD, Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius; President, PCT
CIRM Bridges Meeting
Date and Time: Monday, July 18, 2016, 4:30 PM PT
Venue: Claremont Club & Spa, Berkeley, California
Topic: Succeeding for the Patient: Meeting Manufacturing Demands of Advanced Therapies
Presenter: Robert A. Preti, PhD, Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius; President, PCT
Regenerative Medicine Crossroad
Date and Time: Thursday, July 28, 2016, 1:50 PM JST
Website: https://firm.or.jp/rmit/archives/162
Venue: Nihonbashi Life Science Building, Tokyo, Japan
Topic: Autologous CD34 Cell Therapy for Treatment of Critical Limb Ischemia Under PMDA Agreement
Presenter: Douglas W. Losordo, MD, Senior Vice President Clinical, Medical and Regulatory Affairs and Chief Medical Officer of Caladrius
Caladrius Biosciences SVP and President of PCT, Robert Preti, PhD, Named Chairman of the Alliance for Regenerative Medicine
New York, June 27, 2016 — Caladrius Biosciences (Nasdaq: CLBS), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT, LLC, a Caladrius company) with a select therapeutic development pipeline announces that Robert A. Preti, Ph.D., the Company’s Chief Technology Officer, Senior Vice President, Manufacturing and Technical Operations, and President of PCT, has been named Chairman of the Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the gene and cell therapies and broader regenerative medicine sector. Dr. Preti has served as Vice Chairman of ARM since January 2015 and succeeds Edward Lanphier as Chairman.
Previous to his role as Vice Chairman, Dr. Preti was Executive Committee member and co-chair of the Science and Technology Committee at ARM. As Vice Chair, Dr. Preti has been responsible for the support and promotion of ARM’s global strategy aimed at increasing funding for research and the commercial development of advanced gene- and cell-based therapies, as well as addressing industry issues around regulatory science and reimbursement that will support marketing approval and subsequent commercial acceptance of safe and effective regenerative medicine products.
“It has been a rewarding experience working with ARM both since its founding and in an executive capacity in recent years, and I’m excited to continue that relationship by serving as Chairman,” said Dr. Preti. “ARM’s dedication to advancing regenerative medicine and cell therapies and to bringing its stakeholders together is unprecedented, and aligns with PCT’s own vision of contributing to a world in which transformative cell-based therapeutics are accessible to all patients in need.”
“With this transition, we welcome Bob’s expanded leadership role at ARM as our new chairman,” said Morrie Ruffin, managing director, ARM. “He brings deep knowledge of the organization, unparalleled experience as a leader in the cell and gene therapy sectors and a keen understanding of the clinical and commercial requirements for success.”
Dr. Preti is co-founder of PCT and the visionary behind its successful growth and development over much of the last two decades. Dr. Preti founded PCT to meet a recognized need for high quality manufacturing and development services in an emerging industry. His leadership has been instrumental in creating PCT’s client-focused model that helps bridge the gap between discovery and patient care through efficient transfer of cell-based therapies from laboratory to clinical practice to commercialization.
Before founding PCT, Dr. Preti held a number of positions within the cellular therapy and blood banking fields. In addition, Dr. Preti has served on the Stem Cell Banking Committee and Cord Blood Subcommittee of the New York State Department of Health and on the New Jersey State Department of Health’s Blood Bank Advisory Committee, chairing the Hematopoietic Progenitor Cell Processing Subcommittee. He has served in a leadership capacity for many professional organizations, including Treasurer and founding member of the International Society of Hematotherapy and Graft Engineering, now called ISCT (International Society for Cellular Therapy). He has published and presented extensively on a variety of topics relating to cellular therapies. He recently completed a five-year term as a director for AABB (formerly the American Association of Blood Banks).
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of transformational treatments and cures for patients worldwide.
By leveraging the expertise of its membership, ARM empowers multiple stakeholders to promote legislative, regulatory and public understanding of, and support for, this expanding field.
Based in Washington, DC, ARM promotes legislative, regulatory, reimbursement, investment, technical and other initiatives to accelerate the development of safe and effective regenerative medicine technologies. ARM also works to increase public understanding of the field and its potential to transform human healthcare. Today ARM has more than 240 members and is the leading global advocacy organization in this field.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements. 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 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
Past Press Releases
June 21, 2016
Caladrius Subsidiary, PCT, to Manufacture Phase 3 Cell Therapy Product for Kiadis Pharma
May 26, 2016
Caladrius Biosciences Licenses Cell Therapy Technology for Ovarian Cancer and Subleases Irvine Facility to AiVita Biomedical
May 12, 2016
Caladrius Biosciences Received Orphan Drug Designation for CLBS03 to Treat Type 1 Diabetes
Events
June 22, 2016
ISSCR 2016 Annual Meeting
June 7, 2016
LD Micro Invitational
May 26, 2016
International Society for Cellular Therapy (ISCT) Annual Meeting 2016
Contact Us
Investors:
LHA
Anne Marie Fields
Senior Vice President
Phone: +1-212-838-3777
Email: afields@lhai.com
Media:
Caladrius Biosciences, Inc.
Eric Powers
Director, Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
I am optimistic but on the same hand hesitant! Management has got to get there stuff together! They have the science, they have had the capability BUT bad management has cut there throat each time! Stemcells where the future and we are there now! If they have a good trail and get something to market this company could sky rocket! Every time they are there management has been very poor on getting it moving or giving up for something else!
Your right!
Caladrius Biosciences to Present at Upcoming June Conferences
BASKING RIDGE, N.J., June 1, 2016 – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces today that the Company’s leadership and experts will present at the following upcoming June conferences:
LD Micro Invitational
Date and Time: June 7, 2016, 8 AM PDT
Website: www.events.ldmicro.com
Venue: Luxe Sunset Bel Air, Los Angeles, California
Topic: Company presentation
Presenter: David J. Mazzo, PhD, Chief Executive Officer
ISSCR 2016 Annual Meeting
Date and Time: June 22, 2016, 7:30 PM PDT
Website: www.isscr.org/home/annual-meeting/san-francisco-2016
Venue: Moscone West, San Francisco, California
Poster Topic: CD34+CD45- Cells Isolated From Human Blood Have Molecular and Functional Characteristics of Endothelial Progenitors
Poster Presenter(s): Yajuan Jiang, PhD, Senior Scientist, Associate Director, PCT; David O’Neill, MD, Medical Director and Director, Analytical Development, PCT
Poster To Be Archived At: www.caladrius.com/ISSCR2016poster
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. For more information, visit www.caladrius.com.
I have always thought the companies potential was great and still do! Can they recover??>>>YES they are at the bottom and there is no other place to go, they have the know how, if management can do a good job they will succeed!
I think it is good news that there still working on it
Caladrius Biosciences Licenses Cell Therapy Technology for Ovarian Cancer and Subleases Irvine Facility to AiVita Biomedical
BASKING RIDGE, N.J. (May 26, 2016) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces that it has licensed to AiVita Biomedical, Inc. (“AiVita”) the exclusive global rights to its tumor cell/dendritic cell technology for the treatment of ovarian cancer. In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Company’s strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.
The license contribute's to AiVita's intellectual property protection fof its next generation immunotherapy targeing cancer stem cells. AiVita intends to begin a Phase 2 clinical trial to evaluate the efficacy of its novel approach in ovarian cancer in 2016. To facilitate these clinical objectives, AiVita has also assumed a sublease of the Company’s former Irvine, California facility. This sublease obligation will cover for the remainder of the lease term all cash obligations of Caladrius with respect to the rent and overhead of the Irvine facility.
“Licensing this technology to AiVita is another step forward in streamlining our strategic focus and reducing our operating expenses while monetizing non-core assets through royalty and other milestone-driven transactions,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “This agreement adds to the one signed in February 2016 whereby we licensed to AiVita exclusive global rights to our cell-derived dermatological technology for topical skin applications.”
About AiVita Biomedical
AiVita Biomedical is advancing commercial and clinical-stage programs utilizing curative and regenerative medicines. Built upon expertise in stem cell growth and directed, high- purity differentiation, AiVita Biomedical has engineered safe, efficient and economical manufacturing systems to support the development and commercialization of curative and regenerative medicines.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding AiVita Biomedical’s future development of an ovarian cancer product candidate and launch of a Phase II trial, future royalty or milestone payments to Caladrius and anticipated future cost savings. 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 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
Wonder if this is good news??? http://www.sec.gov/Archives/edgar/data/320017/999999999716022937/filename1.pdf
Caladrius Biosciences Receives Orphan Drug Designation for CLBS03 to Treat Type 1 Diabetes
BASKING RIDGE, N.J., May 12, 2016 -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (“PCT”) with a select therapeutic development pipeline, announces today that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (“T1D”) was granted orphan-drug designation by the US Food and Drug Administration (“FDA”) for the treatment of type 1 diabetes mellitus with residual beta cell function.
Orphan drug designation provides certain exclusivity benefits, tax credits for certain research, longer exclusivity and a waiver of the New Drug Application user fee. The designation is made to promote safe and efficacious products for the treatment of rare diseases. T1D with residual beta cell function is recognized by the FDA as an orphan disease, usually defined as a condition that affects fewer than 200,000 people (prevalence) nationwide.
The scientific basis for this therapeutic stems from the use of Tregs to treat autoimmune diseases caused by T cell imbalances in an individual's immune system. This novel approach seeks to restore immune balance by enhancing Treg cell number and function. Tregs are a natural part of the human immune system and regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, it is thought that deficient Treg activity permits the T effector cells to attack the body's own beneficial cells, and in the case of T1D, insulin-producing pancreatic beta cells.
“Obtaining orphan drug designation is a key step in our regulatory and development strategy for CLBS03,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “Coupled with the progress we are making in advancing the product through to clinical milestones, we believe that this will make CLBS03 an even more attractive opportunity for a potential partner.”
About The Sanford Project: T-Rex Study
The study is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for type 1 diabetes mellitus with residual beta cell function in approximately 111 subjects age 12 to 17 in two cohorts (18 subjects followed by 93 subjects). The study is being conducted in collaboration with Sanford Research, a subsidiary of Sanford Health. Subjects will be randomized into one of three groups and will receive either a high dose of CLBS03, a low dose of CLBS03 or placebo. The key endpoints for the trial are the standard medical and regulatory endpoints for a type 1 diabetes trial and include preservation of C-peptide, an accepted measure for pancreatic beta cell function; insulin use; severe hypoglycemic episodes; and glucose and hemoglobin A1c levels.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. For more information, visit www.caladrius.com.
Leaders in Cell Therapy Development and Manufacturing
Caladrius Biosciences to Present at Multiple Upcoming May Conferences
BASKING RIDGE, N.J., May 9, 2016 – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces today the Company’s leadership and experts will present at multiple upcoming May conferences.
Rebuilding the Failing Heart
Date and Time: Tuesday, May 10, 2016, 12:25 PM CEST
Website: www.cardiocentro.org/Rebuilding-the-Failing-Heart
Venue: Villa Sasso, Lugano, Switzerland
Topic: CD34-Positive Cells and the Rescue of the Failing Heart
Presenter: Douglas W. Losordo, MD, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
13th International Symposium on Stem Cell Therapy and Cardiovascular Innovations
Date and Time: Thursday, May 12, 2016, 4:15 PM CEST
Website: www.cardiovascularcelltherapy.com
Venue: Hospital General Universitario Gregorio Marañón, Madrid, Spain
Topic: Discoveries, Inventions & Breakdown
Discussant: Douglas W. Losordo, MD, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
Terrapinn World Stem Cells Regenerative Medicine Conference
Date and Time: Wednesday, May 18, 2016, 2:40 PM GMT
Website: www.terrapinn.com/conference/world-stem-cells-regenerative-medicine-congress
Venue: Business Design Centre, London
Exhibition Booth: #17
Topic: Scale to Survive: The Future of Cell Therapy
Presenter: Robert Preti, PhD, President of PCT and Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius
International Society for Cellular Therapy (ISCT) Annual Meeting 2016
Website: http://www.isct2016.com/
Venue: Suntec Convention & Exhibition Centre, Singapore
Exhibition Booth: #10a
Session 1
Date and Time: Thursday, May 26, 2016, 7:30 AM SGT
Topic: Innovation for Hire: Contract Development in Cell Therapy
Presenter: Ian Gaudet, PhD, Director, Innovation & Engineering of PCT
Session 2
Date and Time: Friday, May 27, 2016, 7:30 AM SGT
Panel: Managing Challenges to Achieve Optimal Cost of Goods
Panelist: Ian Gaudet, PhD, Director, Innovation & Engineering of PCT
Session 3
Date and Time: Friday, May 27, 2016, 10:45 AM SGT
Topic: A Case Study on Establishing a Global Commercial Enterprise for Cell Therapy Manufacturing
Presenter: George Goldberger, Vice President, Business Development of PCT
GOOD NEWS>>>>> Caladrius Biosciences Reports 2016 First Quarter Financial Results
Total Quarterly Revenues Increase 136% versus Prior Year
Conference Call Begins Today at 5:00 pm Eastern Time
BASKING RIDGE, N.J. (May 5, 2016) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius”), a cell therapy company combining an industry-leading development and manufacturing services provider (through its subsidiary, PCT, LLC a Caladrius CompanyTM (“PCT”)) with a select therapeutic development pipeline, announces financial results for the three months ended March 31, 2016.
Financial and Business Highlights
Achieved total revenues of $7.5 million for the first quarter of 2016, up 136% compared with $3.2 million in the first quarter of 2015 driven by higher Clinical Services revenue at PCT.
Entered into a global collaboration and license agreement with Hitachi Chemical Co. America, Ltd. and Hitachi Chemical Co., Ltd. (collectively, “Hitachi Chemical”), selling a 19.9% equity stake in PCT for $19.4 million and licensing PCT’s cell therapy technology and know-how for certain Asian territories for $5.6 million and future royalties.
Enrolled the first patient in The Sanford Project: T-Rex Study, a Phase 2 trial of CLBS03 (autologous expanded regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (T1D) in adolescents.
Received classification from the European Medicines Agency (EMA) of CLBS03 as an Advanced Therapeutic Medicinal Product (ATMP).
Reached agreement with Japanese regulators on a Phase 2 development plan that could qualify for early conditional approval for CD34 cell therapy as a treatment for critical limb ischemia.
Management Commentary
“The significant revenue growth at PCT along with Hitachi Chemical’s implied valuation of our subsidiary further support our strategy to focus on growth opportunities in the emerging cell therapy manufacturing market,” stated David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “In addition to validating our expertise and know-how, the strategic partnership with Hitachi Chemical strengthens our financial position with $25 million in non-dilutive capital.
“We will continue to leverage the significant momentum in the regenerative medicine and cell therapy industries to grow our PCT business. We believe that the quality of PCT’s services, the increasing number of clinical trials planned and underway and the number of clinical programs nearing commercialization will provide a healthy platform for growth at PCT throughout 2016 and beyond.
“We are delighted that patients are being enrolled in the Sanford Project: T-Rex Study. Sanford Research, a leader of innovation and research in T1D, will provide and cover the costs of two initial clinical trial sites, which are expected to enroll most of if not all of the first cohort of subjects. After this first cohort has completed the three-month post-treatment visit, an interim safety analysis and early analysis of immunological biomarkers will be conducted. With positive results, more sites will be added to facilitate the timely enrollment of the second cohort of this important proof-of-concept study designed to show that CLBS03 can preserve pancreatic beta cell function and lower insulin use in adolescents with recent-onset T1D,” concluded Dr. Mazzo.
First Quarter Financial Highlights
Total revenues for the first quarter of 2016 increased 136% to $7.5 million compared with $3.2 million for the first quarter of 2015. Gross margin on revenues was 17% in the first quarter of 2016, compared with gross margin of negative 6% in the first quarter of 2015.
Research and development (R&D) expenses for the first quarter of 2016 decreased 14% to $5.9 million compared with $6.8 million for the first quarter of 2015. The decrease was primarily related to lower costs subsequent to the discontinuation of Caladrius’ Intus Phase 3 clinical trial as well as decreased costs associated with our ischemic repair platform, compared to the prior year periods. These decreases were partially offset by an increase in expenses related to the initiation of The Sanford Project: T-Rex Phase 2 Study in type 1 diabetes, as well as one-time restructuring costs for severance and asset impairments.
Selling, general and administrative (SG&A) expenses decreased 42% to $6.5 million for the first quarter of 2016 compared with $11.1 million for the same period in 2015, which included expenses associated with executive management changes including one-time new hire compensation-related costs as well as separation-related costs. Equity-based compensation expenses were also significantly lower in the first quarter of 2016 compared to the prior year period.
The operating loss for the first quarter of 2016 was $11.1 million compared with an operating loss of $18.1 million for the first quarter of 2015, reflecting higher gross margin on sales, and lower R&D and SG&A expenses.
Total net loss for the first quarter of 2016 was $12.0 million, and $0.21 per share for Caladrius stockholders, compared with a net loss for the first quarter of 2015 of $19.2 million and $0.51 per share.
Balance Sheet and Cash Flow Highlights
As of March 31, 2016, Caladrius had cash and cash equivalents of $25.4 million. The cash and cash equivalents balance includes the receipt of $22.5 million from the Hitachi Chemical transaction and the payment of $7.0 million to Oxford Finance LLC for repayment of long-term debt, interest and fees. The net cash used in operating activities in the first quarter of 2016 was $8.0 million, compared with $14.2 million in the first quarter of 2015. During the current quarter, Caladrius also invested $1.0 million in capital expenditures primarily related to improvements to PCT’s Allendale, N.J. manufacturing facility.
2016 Financial Guidance
Consolidated Revenues: exceed $30 million (greater than 30% increase compared with 2015) (guidance reaffirmed)
Capital Improvements at PCT’s Allendale, NJ facility: ~$6 million in 2016 (guidance reaffirmed)
CLBS03 Phase 2 Study Costs in 2016: $6 million to $7 million (guidance reaffirmed)
Consolidated Annual Operating Cash Burn: $25 million to $28 million (new guidance) (lower operating cash burn in the second half of 2016 than in the first half of the year)
Conference Call
As previously announced, Caladrius will host a conference call to discuss these 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 95709217.
To access the live webcast, visit the Investor Relations section of the Company’s website at http:/www.caladrius.com/events. The webcast will be archived on the website for 90 days.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements. 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 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
Past Press Releases
April 18, 2016
Caladrius Reaches Agreement with Japanese Regulators on Development Plan for CD34 Cell Therapy for Critical Limb Ischemia
March 29, 2016
Caladrius Biosciences Announces First Subject Treated in CLBS03 Type 1 Diabetes Phase 2 Trial
March 14, 2016
Caladrius Biosciences Subsidiary PCT, LLC Enters into Global Collaboration and License Agreement with Hitachi Chemical
Events
May 5, 2016
2016 First Quarter Financial Results Conference Call
April 28, 2016
Third International Regenerative Medicine Conference 2016
April 27, 2016
GTC Stem Cell Summit 2016
Contact Us
Investors:
LHA
Anne Marie Fields
Senior Vice President
Phone: +1-212-838-3777
Email: afields@lhai.com
Media:
Caladrius Biosciences, Inc.
Eric Powers
Director,
Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
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Leaders in Cell Therapy Development and Manufacturing
Caladrius Biosciences to Present at Multiple Upcoming April Conferences
BASKING RIDGE, N.J., Apr. 20, 2016 – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces today that Company’s Chief Medical Officer, Dr. Douglas Losordo, will present at multiple conferences in the month of April with a primary focus on the company’s T regulatory cell program for type 1 diabetes.
GTC Diabetes Summit 2016
•Website: https://www.gtcbio.com/conferences/diabetes-summit-overview
•Venue: Hyatt Regency, Boston, MA
Session 1
•Date and Time: Monday, April 25, 2016, 4:30 PM ET
•Presenter: Dr. Douglas Losordo, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer
•Topic: Autologous Polyclonal Ex-Vivo Expanded Treg Therapy for New Onset Type 1 Diabetes in Children
Session 2
•Date and Time: Tuesday, April 26, 2016, 1:45 PM ET
•Panelist: Dr. Douglas Losordo
•Topic: Models for Successful Partnerships Among Academia, Government, and Industry
GTC Stem Cell Summit 2016
•Date and Time: Wednesday, April 27, 2016, 9:15 AM ET
•Website: https://www.gtcbio.com/conferences/stem-cell-product-development-commercialization-agenda
•Venue: Hyatt Regency, Boston, MA
•Presenter: Dr. Douglas Losordo
•Topic: Stem Cell Product Development and Commercialization: Challenges in Clinical Efficacy | Autologous CD34 Cell Therapy for Treatment of Cardiovascular Disease. Eight positive clinical trials: Where do we go from here?
Third International Regenerative Medicine Conference 2016
•Date and Time: Thursday, April 28, 2016, 4:50 PM CET
•Website: http://celltherapyconference2016.com/
•Venue: The Vatican, Vatican City
•Panelist: Dr. Douglas Losordo
•Topic: Cell Therapy Research Discussion for Type 1 Diabetes
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements. 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 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
Sorry did not see you had it posted!
Leaders in Cell Therapy Development and Manufacturing
Caladrius Reaches Agreement with Japanese Regulators on Development Plan for CD34 Cell Therapy for Critical Limb Ischemia
Positive Phase 2 trial result will qualify for early conditional approval - Company seeks partner to execute plan
BASKING RIDGE, N.J., April 18, 2016 -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a leading cell therapy company combining an industry-leading development and manufacturing services provider with a select therapeutic product pipeline, announces that the Japanese Pharmaceutical and Medical Devices Agency’s (PMDA) thirty-day review period of the Company’s Clinical Trial Notification (CTN) for a pivotal Phase 2 trial investigating the Company’s CLBS12 product candidate, a CD34 cell therapy for critical limb ischemia (CLI), has now passed without further comment from the PMDA. Accordingly, Caladrius is allowed to proceed with the trial when ready. The Company is seeking a partnership in order to pursue this trial, and is currently in advanced discussions with potential licensing partners. Pending consummation of a partnering agreement, Caladrius expects that the pivotal trial could initiate as early as late 2016.
The Company believes the study design is sufficient to achieve conditional approval for CLBS12 in Japan for the treatment of CLI. The agreed trial is a 35-patient Phase 2, prospective, randomized, controlled, multicenter study in patients with no-option CLI conducted in Japan. Those patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34+ cells (CLBS12) through intramuscular injection in addition to standard of care. Patients randomized to the control arm will receive standard of care pharmacotherapy alone.
“We are pleased that our interactions with the PMDA have led to the design of a relatively small and, we believe, low risk trial that could significantly advance CLBS12 and the Company’s CD34 asset,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “We look forward to achieving a partnership to enable the launch of this pivotal Phase 2 trial in Japan. CLI is just the entry-point to explore the broader applicability of the CD34 platform therapy, which could potentially be effective in the treatment of chronic heart failure or dilated cardiomyopathy.”
Caladrius has decided to aggressively pursue this registration pathway in Japan largely due to the recent Regenerative Medicine Law passed in November 2014. The legislation expedites the development and commercialization of regenerative medicine therapies and grants conditional approval for regenerative medicines that demonstrate safety and the likelihood for efficacy.
“Based on the substantial clinical data from four prior trials in critical limb ischemia and claudication, we believe that CD34 cell therapy is not only safe, but can help improve quality of life and potentially treat patients with this serious and life-threatening condition, which we intend to demonstrate through this pivotal study,” said Dr. Atsuhiko Kawamoto, principal investigator for this pivotal Phase 2 trial for CLBS12.
Dr. Kawamoto is the Director of the Unit of Regenerative Medicine and Leader of the Vascular Regeneration Research Group at the Institute of Biomedical Research and Innovation in Kobe, Japan. He is also the Vice Director of the Translational Research Informatics Center at the Foundation for Biomedical Research and Innovation.
About CLBS12
CD34 cells have been investigated in clinical studies encompassing over 700 patients with over 400 receiving CD34 cell therapy exposure. The scientific rationale for CLBS12 is based on previous studies of autologous CD34 cell therapy for no-option CLI patients in both Japan and the U.S. From those previous studies, researchers found that CD34 cell injection was safe, led to improvement in CLI-free status and improved amputation-free survival and other clinical parameters.
About Critical Limb Ischemia
Critical limb ischemia is a severe obstruction of the arteries which markedly reduces blood flow to the extremities (hands, feet and legs). CLI is an advanced stage of peripheral artery disease, which results from a progressive thickening of an artery’s lining (caused by a build-up of plaque). It can lead to pain, skin ulcers and sores, and if not successfully addressed, eventually amputation. One year after CLI onset, only 50% of patients will remain amputation-free (though may still be symptomatic), 25% will require a major amputation and the remaining 25% will have died. Caladrius’ CD34 cell approach, if successful, could aid patients who currently have no other therapeutic options for this devastating disease.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. Around the core expertise of PCT, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding the consummation of a partnership agreement to initiate a pivotal trial in critical limb ischemia and the achievement of conditional approval for CLBS12 in Japan based on such a trial. 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 15, 2016, and in the Company’s other periodic filings with the SEC, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xxi) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxii) our lack of revenue from product sales; (xxiii) the commercial potential and profitability of our products; (xxiv) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxv) the novelty and expense of the technology used in our cell therapy business; (xxvi) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvii) product liability claims and litigation, including exposure from the use of our products; (xxviii) our potential inability to retain or hire key employees; and (xxix) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
OMG that is when the stock dropped and bottomed out! They had good results and brought the results forward in a way that seemed like they where bad results ! Then one of the clowns that review stocks made a laughing stock out of them (NBS10)! They then did not continue the trail, they waited and put money into NBS20 or I should say clbs20. tHE STOCK DROPPED FROM 8 OR 9 DOLLARS A SHARE TO WHAT IT IS NOW! They dropped the ball and cost investors a load of money including myself! They where doing the stem cell injections in to the heart and had good results then put it on hold to go on to something else! They handled everything very badly IMHO!
This could have been us if they would have not have messed that trail up so bad!!!! http://www.telegraph.co.uk/science/2016/04/04/stem-cell-therapy-halves-deaths-from-heart-failure/
This is interesting!
I hope we see a good increase with all the good news! I agree Akasidney86!
March 3 they started recruiting for the CLBS03! This probably why the upswing! This is the one problem I have with this company is they never inform stock holders what is going on. https://clinicaltrials.gov/ct2/show/NCT02691247?term=Clbs03&rank=1
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Caladrius Biosciences, Inc.
Sponsor:
Caladrius Biosciences, Inc.
Collaborator:
Sanford Health
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02691247
First received: February 12, 2016
Last updated: March 2, 2016
Last verified: February 2016
History of Changes
You can read the rest here:: https://clinicaltrials.gov/ct2/show/NCT02691247?term=Clbs03&rank=1
Caladrius Biosciences to Host 2015 Fourth Quarter and Full Year Financial Results Conference Call on March 15 at 5:00 pm Eastern Time
BASKING RIDGE, N.J. (March 8, 2016) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius”), a cell therapy company combining an industry-leading development and manufacturing services provider with a therapeutic development pipeline, announces today that the Company will release financial results for the fourth quarter and full year of 2015 after the U.S. financial markets close on Tuesday, March 15, 2016.
Caladrius’ management will host a conference call for the investment community beginning at 5:00 pm ET on Tuesday, March 15, 2016, 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 95709216. 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.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. Around this core expertise, Caladrius strategically develops select product candidates, which currently includes an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding our expected revenues and capital expenditures, personnel reductions, as well as the potential of CLBS03 in the treatment of recent-onset type 1 diabetes and the expected cost savings associated with the termination of the CLBS20 study. 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, among other things, future medical and research developments and market acceptance, which are outside of its control.
Leaders in Cell Therapy Development and Manufacturing
Caladrius Biosciences Licenses Dermatology Cell Technology to AiVita Biomedical
Caladrius to Receive Royalties on Product Sales Following Commercial Launch of Topical Skin Product
BASKING RIDGE, N.J. (Feb. 17, 2016) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic product pipeline, has licensed exclusive global rights to its cell-derived dermatological technology for topical skin applications to AiVita Biomedical, Inc. (“AiVita”). This transaction supports the Company’s strategy to monetize non-core assets.
AiVita is a biotechnology company created to advance commercial and clinical stage programs utilizing curative and regenerative medicines. The company was founded in 2016 by Dr. Hans Keirstead, Caladrius’ former Chief Science Officer, and expects to manufacture and distribute a cosmetic skincare product based on the licensed technology for commercial sale beginning in the second quarter of 2016 through ALPHAEON Corporation (“ALPHAEON”). ALPHAEON, a social commerce company in lifestyle healthcare, has an established board-certified physician community of more than 10,000 members coupled with e-commerce capabilities. Caladrius will receive royalties on net sales.
“Licensing this dermatological technology to AiVita is yet another step forward in streamlining our strategic focus while monetizing non-core assets through royalty- and/or other milestone-driven transactions. In this case, the technology fits neither the type nor the scope of manufacturing that is the basis of PCT’s business,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We look forward to ALPHAEON’s launch of this product and to sharing in its economic success.”
About AiVita Biomedical
AiVita Biomedical is advancing commercial and clinical-stage programs utilizing curative and regenerative medicines. Built upon expertise in stem cell growth and directed, high- purity differentiation, AiVita Biomedical has engineered safe, efficient and economical manufacturing systems to support the development and commercialization of curative and regenerative medicines. For more information, visit www.aivitabiomedical.com.
About ALPHAEON Corporation
ALPHAEON Corporation is a social commerce company with the goal of transforming self-pay healthcare by leveraging the power of its professional network of physician specialists to drive lifestyle healthcare advancements, and improve patient experiences and outcomes in the wellness, beauty and performance sectors. For more information, please visit www.alphaeon.com.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. Around this core expertise, Caladrius strategically develops product candidates, which currently include an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation, and holds intellectual property around other cell therapy platform technologies. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding our expected revenues and capital expenditures, personnel reductions, as well as the potential of CLBS03 in the treatment of recent-onset type 1 diabetes and the expected cost savings associated with the termination of the CLBS20 study. 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, among other things, future medical and research developments and market acceptance, which are outside of its control.
Past Press Releases
January 11, 2016
Caladrius Biosciences Out-licenses CD34 Technology to SPS Cardio, LLC for Chronic Heart Failure and Acute Myocardial Infarction
January 6, 2016
Caladrius Tightens Strategic Focus and Provides 2016 Revenue Guidance
December 23, 2015
Caladrius Announces Changes to Its Board of Directors
Events
February 9, 2016
18th Annual BIO CEO & Investor Conference
February 10, 2016
Source Capital's 2016 Disruptive Growth & Healthcare Conference
January 28, 2016
Novel Cardiovascular Therapeutics Summit
Contact Us
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Phone: +1-212-838-3777
Email: afields@lhai.com
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Caladrius Biosciences, Inc.
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Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
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Caladrius Biosciences Announces Presentations at Upcoming Investor Conferences in February
BASKING RIDGE, N.J., January 28, 2016 -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider with a therapeutic development pipeline, announces today that Company management will present at the BIO CEO & Investor Conference and Source Capital’s Disruptive Growth & Healthcare Conference in February.
18th Annual BIO CEO & Investor Conference
•Venue: The Waldorf Astoria, New York, NY
•Website: http://www.bio.org/events/conferences/bio-ceo-investor-conference
•Date and Time: Tuesday, February 9, 2016, 11:30 AM ET
•Presenter: David Mazzo, Ph.D., Chief Executive Officer, Caladrius Biosciences
•Topic: Company Overview
•Webcast: www.caladrius.com/investors/overview (archived for 90 days)
Source Capital’s 2016 Disruptive Growth & Healthcare Conference
•Venue: Convene, New York, NY
•Website: http://clbs.bio/1n6TlDD
•Date and Time: Wednesday, February 10, 2016, 12:30 PM ET
•Presenter: Joseph Talamo, Senior Vice President and Chief Financial Officer, Caladrius Biosciences
•Topic: Company Overview
•Webcast: www.caladrius.com/investors/overview (archived for 90 days)
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges presented by cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. Around this core expertise, Caladrius strategically develops product candidates, which currently include an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation, and holds intellectual property around other cell therapy platform technologies. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding our expected revenues and capital expenditures, personnel reductions, as well as the potential of CLBS03 in the treatment of recent-onset type 1 diabetes and the expected cost savings associated with the termination of the CLBS20 study. 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, among other things, future medical and research developments and market acceptance, which are outside of its control.
BASKING RIDGE, N.J. (January 11, 2016) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider with a therapeutic development pipeline, announces today that it has entered into an agreement with SPS Cardio, LLC (“SPS”) to out-license the patent and commercialization rights to the Company’s CD34 ischemic repair technology (CD34 cell therapy or CLBS10) for the indications of acute myocardial infarction (AMI) and chronic heart failure (CHF) in select territories outside of the U.S. SPS is a venture capital firm that will fund this technology’s further development in these indications and designated countries. SPS intends to conduct a Phase 2 proof-of-concept clinical trial in India to evaluate CD34 cell therapy for the prevention of adverse events in patients with heart failure. This trial will be conducted under internationally accepted cGMP processes and protocols, such that the data will be acceptable for use as part of regulatory submissions to the U.S. Food and Drug Administration and other international regulatory authorities. Caladrius will be eligible to receive royalties together with a milestone upon the successful development and commercialization of any product eventually sold in the selected territories.
Under the agreement, SPS will receive an exclusive license to the CD34 cell therapy technology for use in AMI and CHF in India and in other territories outside the U.S., including selected countries in Asia-Pacific and Latin America. The license does not include the U.S., Europe, Japan, China or South Korea. SPS will cover all costs associated with the further development of the technology in the assigned regions as well as the costs of related intellectual property maintenance and advancement. Caladrius retains the rights to unfettered, cost-free access to and use of any and all clinical and non-clinical data generated in India.
“We are pleased to out-license our CD34 technology in AMI and CHF to SPS as it is in keeping with our strategic focus to build on our core competency in cell therapy process development and manufacturing. Our goal in licensing our various product candidates is to allow us to build on our core, revenue-generating PCT business, while deriving value from the continued development of our clinical assets through royalty and other milestone based payments. This agreement allows us to preserve capital, while retaining our ability to enter into separate development and commercialization partnerships for other indications and in other territories, such as for critical limb ischemia in Japan,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We echo SPS’s enthusiasm for the technology and its development in India and look forward to sharing in their success.”
About CD34 Cell Technology
Caladrius’ technology is designed to utilize CD34 cells to regenerate tissue damaged by ischemic conditions. Ischemia occurs when the supply of oxygenated blood in the body is restricted, causing local tissue distress and death. Ischemia can lead to conditions such as chronic heart failure and critical limb ischemia, conditions for which improving oxygen delivery to affected tissues through the development and formation of new blood vessels initiated or enhanced by CD34 cells could prove therapeutic. Caladrius believes that the positive suggestion of safety and therapeutic activity seen to date in the PreSERVE-AMI Phase 2 study of CLBS10 for ST segment elevation myocardial infarction supports the underlying platform technology.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges presented by cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. Around this core expertise, Caladrius strategically develops product candidates, which currently include an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation, and holds intellectual property around other cell therapy platform technologies. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding our expected revenues and capital expenditures, personnel reductions, as well as the potential of CLBS03 in the treatment of recent-onset type 1 diabetes and the expected cost savings associated with the termination of the CLBS20 study. 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, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xx) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxi) our lack of revenue from product sales; (xxii) the commercial potential and profitability of our products; (xxiii) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxiv) the novelty and expense of the technology used in our cell therapy business; (xxv) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvi) product liability claims and litigation, including exposure from the use of our products; (xxvii) our potential inability to retain or hire key employees; and (xxviii) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which is outside of its control.
Agree
I expect it to drop a lot more! Closing phase 3 was like cutting ones throat! It had a hard time holding between a $1 and $1.25 with phase 3! No wonder Rob went running!!!( Not saying it was her fault)! Every time this company has something good going the something good goes wrong!
Caladrius Biosciences, Inc.
Caladrius expects FY2015 total revenue to be approximately $23 million, an increase of approximately 28% compared with last year. Analysts expect the company to report revenues of $20.29 million for the period.
For 2016, Caladrius expects total revenue to exceed $30 million. Analysts expect the company to report revenues of $32.95 million for the period.
Read more: http://www.nasdaq.com/article/earnings-reported-after-the-bell-jan-6-20160107-00065#ixzz3wYf7ML96
Caladrius Tightens Strategic Focus and Provides 2016 Revenue Guidance
•Emphasizes PCT subsidiary’s leadership position in the emerging cell therapy market with expectations for >30% revenue growth in 2016
•Focuses clinical development on innovative platform of immune modulation with T regulatory cell therapy program in type 1 diabetes
•Discontinues Phase 3 study of CLBS20 as monotherapy for metastatic melanoma and seeks strategic partner for combination therapy and/or other oncology indications
•Conference call begins at 8:30 am Eastern time tomorrow
BASKING RIDGE, N.J. (January 6, 2016) – Caladrius Biosciences, Inc. (“Caladrius” or the “Company”) (NASDAQ: CLBS), a cell therapy company combining an industry-leading development and manufacturing services provider with a therapeutic development pipeline, announces an increased focus of its strategic priorities and provides 2016 revenue guidance based on growth at its PCT subsidiary.
Following a comprehensive review of the Company’s existing operations and development pipeline, as well as an updated assessment of current market dynamics, current and expected future competitive therapies and the Company’s financial resources, Caladrius has decided to shift greater focus and resources to its growing cell therapy process development, optimization and manufacturing services business at its PCT subsidiary. The rapidly developing cell therapy industry, with several cell-based therapies approaching market approvals which are expected to generate additional demand for commercial manufacturing infrastructure, along with PCT’s continued trend of strong revenue growth, supports the Company’s commitment to focus on growth opportunities for PCT. The Company has also reconfirmed its commitment to pursue further development of its immune modulation platform, with a Phase 2 proof-of-concept clinical trial for a T regulatory cell therapy in type 1 diabetes as the primary focus, while choosing to discontinue the current Phase 3 study of CLBS20 as monotherapy for metastatic melanoma.
“Moving forward, we strongly believe PCT represents a compelling opportunity for near- and long-term shareholder value creation and we intend to continue to invest resources in expanding that business, where we are already experiencing noteworthy year-over-year revenue growth,” stated David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius.
“For nearly 17 years, PCT has been an integral partner to the regenerative medicine industry by leveraging its cell therapy-focused, bicoastal development and manufacturing infrastructure to support biotechnology and cell therapy companies,” said Robert A. Preti, Ph.D., Chief Technology Officer of Caladrius and President of PCT. “We continue to focus on the design and implementation of sustainable, scalable, reliable and well-controlled manufacturing processes with optimized cost-of-goods as these are all critical success parameters in bringing new cell therapy and immunotherapy treatments to market. We are looking forward to further acceleration of these activities.”
Dr. Mazzo continued, “The treatment paradigm in metastatic melanoma was transformed during the course of 2015 by the accelerating adoption of multiple immune checkpoint inhibitors used as monotherapy and in combination treatments. These new drugs have significantly improved outcomes in metastatic melanoma and therefore have altered the opportunity for a monotherapy such as CLBS20 in a landscape that is quickly converting to combination therapies. Therefore, we have concluded that, as designed, our current program in metastatic melanoma will not optimally leverage this asset and we will therefore discontinue the ongoing Phase 3 clinical study with CLBS20 as a monotherapy for the treatment of recurrent Stage III or Stage IV metastatic melanoma. As a result, we will reduce associated staff by approximately 40 employees at our Irvine, California facility. That said, we continue to believe in the potential of CLBS20 as a life-prolonging immunotherapeutic and will pursue licensing or partnership opportunities for its continued development as part of a combination therapy and in different oncology indications. The emphasis will be on collaborating with a company that will allow us to exploit the novel antigen presentation and T cell activation approach of CLBS20.”
On the development front, Caladrius will focus its efforts on its T regulatory (Treg) cell therapy product candidate, CLBS03. CLBS03 is based on the Company’s novel immune modulation approach that seeks to restore immune balance by enhancing Treg cell number and function. The Company is planning to commence enrollment in a Phase 2 study for adolescents with recent-onset type 1 diabetes in the first quarter of 2016, in collaboration with Sanford Research, a non-profit research organization that supports an emerging translational research center focused on finding a cure for type 1 diabetes.
“The opportunity provided by polyclonal T cells in the treatment of autoimmune diseases is compelling and we are excited to be at the forefront of this technology’s development and to be working with recognized leaders in the field, such as Drs. Jeffrey Bluestone and Stephen Gitelman of the University of California, San Francisco and Dr. Kevan Herold of Yale University. We believe CLBS03 has the potential to be paradigm-changing in the treatment of recent-onset diabetes and, potentially, other autoimmune diseases. We look forward to initiating our Phase 2 clinical program in conjunction with Sanford Research in the first quarter of 2016,” concluded Dr. Mazzo.
Financial Guidance
For 2015, Caladrius expects total revenue to be approximately $23 million, representing an increase of approximately 28% compared with 2014. For 2016, Caladrius expects total revenue to exceed $30 million, representing an increase of greater than 30% compared with the expected results for 2015. In order to accommodate this projected growth, Caladrius has budgeted to spend $6 million in capital improvements to increase PCT’s Allendale, N.J. clean room capacity by 60%, and expects to complete the build-out in 2016. Caladrius also estimates that it will incur restructuring charges of approximately $1.0 million in connection with one-time employee termination costs, including severance and other benefits, in the first quarter of 2016. The Company estimates that the staff reduction will result in over $4 million in annualized compensation-related savings, and anticipates significant cost savings associated with terminating the CLBS20 study, which had been estimated to cost $35 million through its completion. In addition, with a narrowed focus on research and development initiatives, as well as a re-sizing of the Company’s general and administrative infrastructure, Caladrius expects to lower R&D, G&A and overall cash burn in 2016 compared to 2015. The Company also expects to incur significant non-cash intangible asset and goodwill impairment charges associated with the termination of the CLBS20 study and will assess the impact as of December 31, 2015 during its annual intangible asset impairment review process.
Conference Call
Company management will host a conference call to discuss this announcement on January 7, 2016, at 8:30 am Eastern time. To participate in the conference call, dial 877-562-4460 (U.S.) or 513-438-4106 (international) and provide conference ID 15555219. To access the live webcast, visit the Investor Relations section of the Company’s website at www.caladrius.com/investors/overview/. The webcast will be archived on the website for 90 days.
About Caladrius Biosciences
Caladrius Biosciences, Inc., through its wholly-owned subsidiary, PCT, is a leading development and manufacturing partner to the cell therapy industry. Caladrius works with its clients to overcome the fundamental challenges presented by cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. Around this core expertise, Caladrius strategically develops product candidates, which currently include an innovative therapy for type 1 diabetes based on a proprietary platform technology for immunomodulation, and holds intellectual property around other cell therapy platform technologies. 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. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding our expected revenues and capital expenditures, personnel reductions, as well as the potential of CLBS03 in the treatment of recent-onset type 1 diabetes and the expected cost savings associated with the termination of the CLBS20 study. 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, including: risks related to: (i) our expected continued losses and negative cash flows; (ii) our anticipated need for substantial additional financing; (iii) the significant costs and management resources required to comply with the requirements of being a public company; (iv) the possibility that a significant market for cell therapy may not emerge; (v) the potential variability in PCT’s revenues; (vi) PCT’s limited manufacturing capacity; (vii) the need to improve manufacturing efficiency at PCT; (viii) the limited marketing staff and budget at PCT; (ix) the logistics associated with the distribution of materials produced by PCT; (x) government regulation; (xi) our intellectual property; (xii) cybersecurity; (xiii) the development, approval and commercialization of our products; (xiv) enrolling patients in and completing, clinical trials; (xv) the variability of autologous cell therapy; (xvi) our access to reagents we use in the clinical development of our cell therapy product candidates; (xvii) the validation and establishment of manufacturing controls; (xviii) the failure to obtain regulatory approvals outside the United States; (xix) our failure to realize benefits relating to “fast track” and “orphan drug” designations; (xx) the failure of our clinical trials to demonstrate the safety and efficacy of our product candidates; (xx) our current lack of sufficient manufacturing capabilities to produce our product candidates at commercial scale; (xxi) our lack of revenue from product sales; (xxii) the commercial potential and profitability of our products; (xxiii) our failure to realize benefits from collaborations, strategic alliances or licensing arrangements; (xxiv) the novelty and expense of the technology used in our cell therapy business; (xxv) the possibility that our competitors will develop and market more effective, safer or less expensive products than our product candidates; (xxvi) product liability claims and litigation, including exposure from the use of our products; (xxvii) our potential inability to retain or hire key employees; and (xxviii) risks related to our capital stock. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
Caladrius Biosciences’ (CLBS) Buy Rating Reiterated at Maxim Group
December 28th, 2015 - By Maddie Sorensen - 0 comments
Caladrius Biosciences logoCaladrius Biosciences (NASDAQ:CLBS)‘s stock had its “buy” rating restated by equities research analysts at Maxim Group in a research report issued on Monday, AnalystRatings.Net reports.
CLBS has been the subject of a number of other research reports. Zacks Investment Research upgraded Caladrius Biosciences from a “sell” rating to a “hold” rating in a research note on Tuesday, September 15th. WBB Securities restated a “buy” rating and issued a $7.00 price target on shares of Caladrius Biosciences in a research note on Thursday, September 24th. One equities research analyst has rated the stock with a hold rating and six have issued a buy rating to the company. Caladrius Biosciences currently has a consensus rating of “Buy” and a consensus price target of $9.67.
Shares of Caladrius Biosciences (NASDAQ:CLBS) traded down 2.59% during midday trading on Monday, reaching $1.13. The company’s stock had a trading volume of 218,040 shares. The firm’s market cap is $62.57 million. The stock’s 50 day moving average price is $1.16 and its 200 day moving average price is $1.53. Caladrius Biosciences has a one year low of $1.01 and a one year high of $4.26.
Caladrius Biosciences, Inc., formerly NeoStem, Inc., is a clinical-stage biopharmaceutical company. The Company’s clinical program is based on its dendritic cell and cancer cell technology. It is focused on the development of a cancer treatment designed to focus the cells responsible for tumor growth and metastasis, known as cancer or tumor initiating cells (NASDAQ:CLBS). Its lead product candidate based on this platform technology is NBS20 (targeted cancer immunotherapy), which is in Phase II trials focuses on malignant melanoma as an initial indication. Its therapeutic platforms also include ischemic repair (CD34 Cell Program) and immune modulation (T Regulatory Cell Program). Its CD34 Cell Program develops therapies designed to address diseases and conditions caused by ischemia. Its product candidate in CD34 Cell Program is NBS10, which has completed Phase I clinical trials. Under T Regulatory Cell Program, the Company is developing NBS03D, which is in the Phase I clinical trial stage
http://www.dakotafinancialnews.com/caladrius-biosciences-clbs-buy-rating-reiterated-at-maxim-group/767227/
Caladrius Announces Changes to Its Board of Directors
BASKING RIDGE, N.J. (December 23, 2015) – Caladrius Biosciences, Inc. (“Caladrius” or the “Company”) (NASDAQ: CLBS), a cell therapy company combining an industry-leading development and manufacturing services provider with a therapeutic development pipeline, announces the appointment of Steven S. Meyers, previously the Board’s lead independent Director, as interim Chairman of the Board, subsequent to the resignation of Robin L. Smith, M.D, as Chairman of the Board and a Director. In addition, the Company announces the appointment of Robert A. Preti, Ph.D., Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius Biosciences, to its Board of Directors. With these changes, the Caladrius Biosciences Board remains at eight Directors.
“We are delighted to welcome Dr. Preti to the Board as we believe his in-depth knowledge of and experience with cell therapy development and manufacture will provide us with invaluable insight and guidance as we continue to build our PCT business as an important foundational asset and driver of future value for our Company,” stated David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius Biosciences. “We thank Dr. Smith for her many years of service to the Company and its Board and wish her well in her future endeavors.”
Dr. Preti is the President and co-founder of PCT, a Caladrius company, and the visionary behind its successful growth and development strategy over much of the last two decades. As Chief Technology Officer of Caladrius he is involved in assessing and directing the development of Caladrius’ cell therapy pipeline, as well as participating in setting the Company’s strategic direction.
Dr. Preti built PCT to meet a recognized need for high quality manufacturing and development services in an emerging industry. As the cell therapy field has grown, so too has PCT— the company has now served over 120 clients and performed more than 20,000 cell therapy procedures. His leadership has been instrumental in creating PCT’s client-focused model that helps bridge the gap between discovery and patient care through efficient transfer of cell-based therapies from laboratory to clinical practice to commercialization.
Before assuming his role at PCT, Dr. Preti held a number of positions within the cellular therapy and blood banking fields. From 1996 to 1999, he was the director of hematopoietic stem cell processing and applied research at Hackensack University Medical Center in Hackensack, N.J. He served in several capacities with the New York Blood Center from 1990 to 1997, including tissue bank director, director of hematopoietic stem cell processing, scientific director and associate investigator. He also worked as a research scientist for Marrow-Tech Incorporated, which went on to become Advanced Tissue Sciences (ATIS), where work in his laboratory lead to the Dermagraft product currently marketed by Organogenesis.
In addition, Dr. Preti has served on the Stem Cell Banking Committee and Cord Blood Subcommittee of the New York State Department of Health and on the New Jersey State Department of Health’s Blood Bank Advisory Committee, chairing the Hematopoietic Progenitor Cell Processing Subcommittee. He has served in a leadership capacity for many professional organizations, including treasurer and founding member of the International Society of Hematotherapy and Graft Engineering, now called ISCT (International Society for Cellular Therapy). He has published and presented extensively on a variety of topics relating to cellular therapies. He recently completed a five year term as a director for AABB, and is currently Vice Chairman for the Alliance for Regenerative Medicine (ARM), where, among other activities, he co-chaired the Standards and Technology Committee.
Dr. Preti holds a Bachelor of Science degree in biology from Fordham University, and a Master of Science degree and Doctorate, both in biology, from New York University
I love this stock! It has so much potential BUT it never seems to get its feet off ground! I AM HOLDING TO THE FINAL RESULTS ON PHASE 3 THEN I AM GOING TO DECIDE WHICH WAY TO GO!
Caladrius Biosciences (NASDAQ:CLBS) Receives $10.80 Consensus PT from Analysts
Posted on December 17, 2015 by Micah Smith in Investing, Consensus Rating Articles
Caladrius Biosciences logoCaladrius Biosciences (NASDAQ:CLBS) has received an average rating of “Buy” from the seven analysts that are currently covering the stock, AnalystRatingsNetwork.com reports. One research analyst has rated the stock with a hold rating and six have given a buy rating to the company. The average 1-year price target among analysts that have covered the stock in the last year is $10.80.
Caladrius Biosciences (NASDAQ:CLBS) opened at 1.06 on Monday. Caladrius Biosciences has a one year low of $1.02 and a one year high of $4.26. The stock’s market capitalization is $58.70 million. The firm has a 50-day moving average of $1.19 and a 200 day moving average of $1.57.
Several analysts recently issued reports on the stock. Zacks Investment Research upgraded shares of Caladrius Biosciences from a “hold” rating to a “buy” rating in a report on Thursday, November 26th. Maxim Group restated a “buy” rating on shares of Caladrius Biosciences in a report on Thursday, September 24th. Finally, WBB Securities restated a “buy” rating and issued a $7.00 price objective on shares of Caladrius Biosciences in a report on Thursday, September 24th.
Caladrius Biosciences, Inc., formerly NeoStem, Inc., is a clinical-stage biopharmaceutical company. The Company’s clinical program is based on its dendritic cell and cancer cell technology. It is focused on the development of a cancer treatment designed to focus the cells responsible for tumor growth and metastasis, known as cancer or tumor initiating cells (NASDAQ:CLBS). Its lead product candidate based on this platform technology is NBS20 (targeted cancer immunotherapy), which is in Phase II trials focuses on malignant melanoma as an initial indication. Its therapeutic platforms also include ischemic repair (CD34 Cell Program) and immune modulation (T Regulatory Cell Program). Its CD34 Cell Program develops therapies designed to address diseases and conditions caused by ischemia. Its product candidate in CD34 Cell Program is NBS10, which has completed Phase I clinical trials. Under T Regulatory Cell Program, the Company is developing NBS03D, which is in the Phase I clinical trial stage.document.write(‘‘);
http://www.storminvestor.com/caladrius-biosciences-nasdaqclbs-receives-10-80-consensus-pt-from-analysts/186461/
ROFLMAO I had a average price of around 5 or 6! When they started going down I took a loss and sold a lot off them starting buying back at the 1-2 dollar level! I had to sell and buy back cheaper to get some of my loss back! I have sold and bought quite a few times, every time it heads up I have been selling some off and buying back when it goes down! I usually do not do this BUT I had such a high loss when it started dropping that I had to do this to recoup some of my money.
Thanks for the article Lunatic!! Good read!