Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
(a)

 
On February 25, 2016, Caladrius Biosciences, Inc. (the “Company”) received written notice from the Listing Qualifications Department of The NASDAQ Stock Market LLC (“NASDAQ”) notifying the Company that for the preceding 30 consecutive business days, the Company’s common stock did not maintain a minimum closing bid price of $1.00 (“Minimum Bid Price Requirement”) per share as required by NASDAQ Listing Rule 5550(a)(2). The notice has no immediate effect on the listing or trading of the Company’s common stock and the common stock will continue to trade on The NASDAQ Capital Market under the symbol “CLBS” at this time.
 
In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until August 23, 2016, to regain compliance with NASDAQ Listing Rule 5550(a)(2). Compliance can be achieved automatically and without further action if the closing bid price of the Company’s stock is at or above $1.00 for a minimum of 10 consecutive business days at any time during the 180-day compliance period, in which case NASDAQ will notify the Company of its compliance and the matter will be closed.
 
If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by August 23, 2016, the Company may be eligible for additional time to comply. In order to be eligible for such additional time, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The NASDAQ Capital Market, with the exception of the Minimum Bid Price Requirement, and must notify NASDAQ in writing of its intention to cure the deficiency during the second compliance period.

Management Discussion and Analysis

Clinical Services were approximately $4.1 million for the three months ended September 30, 2015 compared to $2.1 million for the three months ended September 30, 2014, representing an increase of approximately $2.0 million or 97%. The increase was primarily due to $2.1 million of higher clinical manufacturing revenue. 

  ◦ Process Development Revenue - Process development revenues were approximately $0.6 million for the three months ended September 30, 2015 compared to $0.7 million for the three months ended September 30, 2014. In accordance with our revenue recognition policy, process development revenue is recognized upon contract completion (i.e., when the services under a particular contract are completed). As a result, unearned revenue relating to process development contracts increased from $3.6 million as of June 30, 2015 to $4.3 million as of September 30, 2015. Process development revenue will continue to fluctuate from period to period as a result of our process development revenue recognition policy, and the timing upon when services for a contract are completed.

  ◦ Clinical Manufacturing Revenue - Clinical manufacturing revenues were approximately $3.5 million for the three months ended September 30, 2015 compared to $1.4 million for the three months ended September 30, 2014. The increase is primarily due to an increase in the number of patients our customers have enrolled and treated in clinical trials, which number varies depending on the stage of the clinical trial.

• Clinical Services Reimbursables were approximately $0.9 million for the three months ended September 30, 2015 compared to $1.0 million for the three months ended September 30, 2014, representing a decrease of approximately $0.1 million, or 10%. Generally, clinical services reimbursables correlate with clinical services revenues. However, differences in the cost of supplies to be reimbursed can vary greatly from contract to contract based on the cost of supplies needed for each client's manufacturing and development process and may impact this correlation. In addition, our terms for billing reimbursable expenses do not include a significant mark-up in the acquisition cost of such consumables, and as a result, changes in this revenue category have little impact on our gross profit and net loss.

• Processing and Storage Services were approximately $0.9 million for the three months ended September 30, 2015 compared to $1.1 million for the three months ended September 30, 2014, representing a decrease of approximately $0.1 million or 14%. The decrease was primarily due to lower volume for our oncology stem cell processing services.

Caladrius Biosciences, Inc.
Common Stock

Pursuant to this prospectus supplement and the accompanying prospectus, we are offering up to $30,000,000 plus 842,696 Commitment Shares of our common stock, par value $0.001 per share (“Common Stock”), to Aspire Capital Fund, LLC under a Common Stock Purchase Agreement entered into on November 4, 2015.

The shares offered include (i) 842,696 shares of Common Stock to be issued to Aspire Capital Fund, LLC in consideration for entering into the Common Stock Purchase Agreement and (ii) additional shares of Common Stock with an aggregate offering price of up to $30,000,000 which may be sold from time to time to Aspire Capital Fund, LLC until November 4, 2017. The purchase price for the additional shares of stock will be based upon one of two formulas set forth in the Common Stock Purchase Agreement depending on the type of purchase notice we submit to Aspire Capital from time to time.

Our Common Stock is listed on The NASDAQ Capital Market under the symbol “CLBS.” On November 3, 2015, the last reported sale price of our common stock was $1.35 per share.

NEW YORK, June 8, 2015 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq:CLBS) ("Caladrius" or the "Company"), a cell therapy leader with a late-stage clinical program for immuno-oncology, today announced that its Chief Executive Officer, Dr. David J. Mazzo, has issued a letter to shareholders. The letter begins as follows:

Dear Fellow Shareholders of Caladrius Biosciences,

The first five months of my tenure as the Chief Executive Officer of Caladrius Biosciences (formerly NeoStem) have been hectic, stimulating and enlightening. I can assure you that I am as excited as ever about our prospects to bring new, innovative and treatment paradigm-changing medical therapies to bear on diseases with high unmet medical need. I also remain confident that our objective to significantly enhance shareholder value will become a reality as we continue to execute our strategic business plan. But before I detail our exciting company milestones, both recent and upcoming, allow me to begin with a few words about our new identity.

Effective today, NeoStem has changed its name to Caladrius Biosciences, Inc. The name change marks the culmination of our efforts to identify clearly our company by its new, focused and rationalized pipeline in combination with our unique approach to cell therapy development and manufacturing services. In Roman mythology, the Caladrius is a bird that visits the ill and is said to be able to absorb a patient's illness and fly away, dispersing the illness and healing both itself and the patient. With the same objective of patient recovery, we, now as Caladrius Biosciences, are committed to bringing significant life-improving therapies to market, driving the evolution of the cell therapy industry and generating industry-leading growth through our innovation and executional excellence. Among the first of a new breed of immunotherapy companies, we strive every day, through the development of our own individualized cell therapies as well as through successful development and manufacturing partnerships, to deliver unique and better medical treatments to market.

Item 8.01 Other Events.

On May 27, 2015, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Aegis Capital Corp. (the “Underwriter”), pursuant to which the Company agreed to issue and sell to the Underwriter 12,500,000 shares (the “Offered Shares”) of Common Stock at a public offering price of $2.00 per share. The Company also granted the Underwriter a 45-day option to purchase up to 1,875,000 additional shares of Common Stock (the “Option Shares” and, together with the Offered Shares, the “Shares”).

The Company has agreed to indemnify the Underwriter against certain liabilities, including civil liabilities under the Securities Act of 1933, as amended (the “Securities Act”), or to contribute payments that the Underwriter may be required to make in respect of these liabilities. In addition, the Underwriting Agreement contains customary representations, warranties and agreements of the Company and the Underwriter, as well as customary conditions to closing.

The foregoing is a summary description of certain terms of the Underwriting Agreement and is qualified in its entirety by the text of the Underwriting Agreement attached hereto as Exhibit 1.1 and incorporated herein by reference.

On May 27, 2015, the Company issued (i) a press release announcing the Company’s underwritten public offering (the “Offering”) and (ii) a press release announcing the pricing of the Offering. Copies of the press releases are attached hereto as Exhibit 99.1 and Exhibit 99.2.

The offering and sale of the Shares have been registered under the Securities Act, pursuant to the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-183543).

On May 28, 2015, Paul Hastings LLP delivered its legality opinion with respect to the Shares, a copy of which is attached hereto as Exhibit 5.1.

NeoStem, Inc.

12,500,000 Shares Common Stock

NEW YORK, May 27, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS) ("NeoStem" or the "Company"), announced today the pricing of an underwritten public offering of 12,500,000 shares of common stock at a public offering price of $2.00 per share. The gross proceeds to NeoStem from this offering are expected to be $25,000,000 before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company has granted the underwriter a 45-day option to purchase up to an aggregate of 1,875,000 additional shares of its common stock to cover over-allotments, if any. The Company intends to use the net proceeds from this offering for working capital, including research and development of cell therapeutic product candidates, especially its lead immuno-oncology program, NBS20, expansion of business units, strategic transactions and other general corporate purposes. The offering is expected to close on or about June 2, 2015, subject to the satisfaction of customary closing conditions.

Aegis Capital Corp. is acting as sole book-running manager for the offering.

NeoStem, Inc.

NEW YORK, May 21, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) announced Thursday that it will receive one of the largest research grants of its kind to support its pioneering treatment for patients with stage III recurrent or stage IV metastatic melanoma, a potentially breakthrough approach that teaches the immune system which cells to attack and kill.

The $17.7 million grant from the California Institute for Regenerative Medicine (CIRM), a distinguished and independent scientific body, is a significant endorsement of the potential for NeoStem's novel approach for treating metastatic melanoma, the most deadly form of skin cancer. The sheer scope of the award has important implications as it is expected to fund a significant portion of the pivotal Phase 3 clinical trial investigating a personalized cancer treatment and currently enrolling patients at centers across the United States.

NeoStem's therapeutic candidate, NBS20, uses a patient's own cancer cells � in essence, turning the cancer against itself � in a way that is unique. Instead of attacking the bulk of cancer cells, NeoStem's therapy targets a patient's cancer-initiating cells, often called "cancer stem cells," which are those that proliferate cancer cells, spreading the disease and forming new tumors throughout the body.

Trial results to date support the expectation that this novel approach will improve overall survival. In a Phase 2 randomized, controlled trial of the therapy, results showed a 72 percent two-year survival rate, compared with 31 percent in the control group.

NeoStem's belief is that if the Phase 3 trial is successful, and the therapy is then approved by the FDA, it could be a breakthrough in the treatment of metastatic melanoma patients and available as early as 2018.

The product candidate has been granted both Fast Track and Orphan Drug designations from the FDA, and the protocol is the subject of a Special Protocol Assessment with FDA. Additionally, the European Medicines Agency has classified NBS20 as an Advanced Therapeutic Medicinal Product.

"We are grateful to CIRM and the cancer experts who reviewed and endorsed our application. We firmly believe that this therapy has the potential to help people survive cancer longer and this grant helps us advance towards bringing this treatment to market," said Dr. David J. Mazzo, NeoStem's Chief Executive Officer. "The grant substantiates our approach to identifying and securing non-dilutive funding for our development programs and helps position NeoStem as a leader among immuno-oncology therapy developers."

The grant comes during National Melanoma Skin Cancer Awareness Month and just ahead of the summer outdoor season when preventing skin cancer � the most common type of cancer in the United States � is a priority.

Norm Beegun, a patient in one of the Phase 2 trials for NBS20 who lives in Los Angeles, California, commented, "After several years of receiving other treatments with limited long-term success, I have been disease-free for the past 11 years since the NeoStem treatment � and I remain so today. The medical need for those with late-stage melanoma is profound, but so is the potential of this therapy. It deserves attention and support. That's why I am so glad that CIRM is funding the kind of research that can help so many people."

NeoStem's research has potentially widespread applications for people with cancers of various solid tumor types, including ovarian, lung, colon, liver, renal and brain cancers.

Other therapies may treat existing cancer, but they may not be as likely as NeoStem's approach might be to prevent a recurrence of tumors. NeoStem is one of a small group of companies with an immunotherapy product actually in Phase 3 development.

NeoStem is a biopharmaceutical company developing novel personalized immuno-oncology medical treatments. CIRM, whose mission it is to accelerate the availability of stem cell treatments for patients with unmet medical needs, funds promising research programs involving all types of stem cells and across a wide range of diseases.

The grant is the largest CIRM has made since its Dec 31, 2014 official launch of CIRM 2.0 and one of the largest the organization has ever made to an industry sponsor. Use of any of the CIRM grant funds is subject to dollar-for-dollar match funding by NeoStem.

"CIRM 2.0 is designed to accelerate the development of treatments for people with unmet medical needs, and this project clearly fits that description," says Dr. C. Randal Mills, President and CEO of CIRM. "With the Board's approval today we will now get this work up and running within the next 45 days. But that's just the start. We are not just providing financial support; we are also partnering with these groups to provide expertise, guidance and other kinds of support that these teams need to help them be successful. That's the promise of CIRM 2.0. Faster funding, better programs and a more comprehensive approach to supporting their progress."

Unlike many other immuno-oncology products, in order to work as hypothesized NBS20 does not depend on a low-level intrinsic immune response from the patient. The therapy is intended to induce an immune response by "teaching" the immune system what cells to attack and kill. Furthermore, because of its unique mechanism of action, the therapy will likely be complementary and potentially even synergistic with other available therapies. It is expected to be very well tolerated by patients because it uses their own immune system to create a specific therapy.

The Intus trial is supported by results from two Phase 2 trials conducted with dendritic cells loaded with antigens from autologous tumor stem cells, now known as NBS20. The more recent of the two trials was a randomized trial comparing subcutaneous injections of NBS20 versus injections of autologous irradiated (inactivated) tumor stem cells in patients with advanced melanoma. The two-year survival rate of 72 percent corroborated one of the findings of the previous Phase 2 trial, in which a 73 percent two-year survival rate was demonstrated along with a five-year survival rate of 50 percent.

The U.S. melanoma market is approximately $1 billion per year, which is predominantly spent to treat metastatic melanoma.

NeoStem, Inc.
Common Stock

Pursuant to this prospectus supplement and the accompanying prospectus, we are offering up to $30,000,000 plus 364,837 Commitment Shares of our common stock, par value $0.001 per share (“Common Stock”), to Aspire Capital Fund, LLC under a Common Stock Purchase Agreement entered into on May 4, 2015.

The shares offered include (i) 364,837 shares of Common Stock to be issued to Aspire Capital Fund, LLC in consideration for entering into the Common Stock Purchase Agreement and (ii) additional shares of Common Stock with an aggregate offering price of up to $30,000,000 which may be sold from time to time to Aspire Capital Fund, LLC until May 4, 2017. The purchase price for the additional shares of stock will be based upon one of two formulas set forth in the Common Stock Purchase Agreement depending on the type of purchase notice we submit to Aspire Capital from time to time.

• Total revenue for the quarter was approximately $3.2 million compared to $4.1 million for Q1 2014, a decrease of 22%, which was primarily due to lower reported Clinical Services revenues. 
• Net loss for Q1 2015 was approximately $19.2 million compared to net loss of $13.8 million for Q1 2014. Net loss for Q1 2015 excluding non-cash charges was $14.3 million, compared with $9.3 million for Q1 2014

"NeoStem has completed our transformation into a Phase 3 immuno-oncology company with the recent randomization of the first patient in the pivotal Phase 3 Intus trial for NBS20. This is a trial that has been granted a Special Protocol Assessment (SPA) by the FDA. In addition, the NBS20 program has been granted Orphan Drug and Fast Track designations by FDA, all based on compelling published Phase 2 results. We look forward to advancing this therapy towards addressing the significant unmet need of metastatic melanoma treatment," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem.

2015 Outlook

In 2015, NeoStem's management expects significant additional achievements, principal among them are the following:

• Continued enrollment in the Intus Phase 3 trial for NBS20;
• Change of corporate name and brand identity in the coming weeks to emphasize the Company's therapeutic development focus on immune therapy and its integrated approach to cell therapy;
• Filing an IND in Japan for one or more programs under Japan's new regenerative medicine law which enables an expedited path to conditional approval for regenerative medicine products based on the demonstration of sufficient safety evidence and signals of efficacy;
• Finalization of decision on next development steps for NBS10 based on available PreSERVE results;
• Receipt of additional non-dilutive (i.e., grant) funding to support development programs;
• Continued growth in the Company's client services (PCT) busine

NEW YORK, April 29, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today the randomization of the first patient in the Intus Phase 3 clinical trial investigating the efficacy of the Company's patient-specific targeted cancer immunotherapy candidate NBS20 (USAN = eltrapuldencel-T) in patients with stage III recurrent or stage IV metastatic melanoma. The Intus trial has been granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA), which permits this trial, if successful, to be the sole pivotal trial necessary for registration. The NBS20 development program has also been granted Orphan Drug and Fast Track designations by the FDA.

The Intus trial is based on consistent, compelling results from two Phase 2 trials in identical patient populations evaluating the therapeutic vaccine that has become NBS20. The more recent of the two trials was a randomized trial comparing NBS20 to injections of autologous irradiated (inactivated) tumor cells in 42 patients. At two years, survival was 72% compared to 31% for control patients (p=0.007), which was consistent with the previous Phase 2 trial's findings in which NBS20 demonstrated 73% two-year survival in 54 patients, with a median survival of five years. Toxicity was minimal and consisted of mild to moderate local injection site reactions of the type normally associated with injections of GM-CSF (a protein secreted by immune cells that helps stimulate other immune cells to promote immune defenses against disease).

"The randomization of the first patient in the pivotal Phase 3 trial for NBS20 represents the achievement of a significant milestone for NeoStem, marking our transformation into a Phase 3 immuno-oncology company. We are now part of a select group of immunotherapy companies at such an advanced clinical development stage," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem.

The Intus study is a multi-national, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which stage III recurrent or stage IV metastatic melanoma patients will be randomized in a 2:1 ratio to receive either NBS20 (autologous dendritic cells loaded with antigen from self-renewing, proliferating autologous tumor cells in GM-CSF) or a control treatment (peripheral blood mononuclear cells obtained from apheresis product in GM-CSF). The study is expected to randomize 250 eligible patients across approximately 50 sites internationally (US, Canada, Australia, New Zealand and, potentially, select countries of the EU); each patient will receive subcutaneous injections once weekly for three consecutive weeks, and then once monthly for five months.

"We are pleased to take another step in our efforts to demonstrate the efficacy of this patient-specific therapy in the hope of improving long-term survival of patients with metastatic melanoma, especially given approval of recent therapies that have yielded strong response rates without demonstrating substantial impact on survival," said Dr. Robert Dillman, Vice President, Oncology of NeoStem and founder of the NBS20 technology.

In addition to metastatic melanoma, the platform technology on which NBS20 is based is potentially applicable across multiple solid tumor types, including advanced lung, colon, kidney, ovarian and hepatocellular carcinomas, and glioblastoma multiforme�indications that collectively lead to more than 200,000 deaths in the United States each year.

LAKE FOREST, Calif., April 29, 2015 /PRNewswire/ -- Cryoport, Inc. (CYRX) ("Company"), the leading provider of advanced cryogenic logistics solutions for the life sciences industry, serving markets including immunotherapies, stem cells, cell lines, clinical research organizations, vaccine manufacturers and reproductive medicine, today announced that the Company is supporting NeoStem, Inc.'s (NBS) Intus Study to evaluate its lead cancer immunotherapy, NBS20, for the treatment of metastatic melanoma.

NeoStem, a biopharmaceutical company, is developing an autologous immunotherapy that uses a patient's own tumor cells to maximize the immune system's ability to identify and eliminate the cancer initiating cells that NeoStem believes are capable of reconstituting and developing new tumors.  The proposed therapeutic combines a patient's own purified and irradiated cancer cells with specialized immune cells, educating the immune cells to destroy the cancer initiating cells from which tumors arise.  The Intus Study for the treatment of metastatic melanoma has received Special Protocol Assessment and the program has received Fast Track and Orphan Drug Designations from the US Food and Drug Administration ("FDA").

Cryoport's best-in-class cryogenic logistics solution is providing comprehensive support for NeoStem's Intus Study, which is advancing to a Phase 3 trial.  The Company is an important partner to the NBS20 development program as it launches the multi-center trial and provides access to enrolled patients to the cryopreserved, cell-based therapy that could potentially treat the rapid progression of the deadly cancer.

David J. Mazzo, Ph.D., Chief Executive Officer of NeoStem, commented, "At NeoStem, we are dedicated to preserving and enhancing  human health through the development of novel cell-based individualized therapies like our lead Phase 3 program in immuno-oncology, the Intus Study, targeting the treatment of late-stage melanoma. Cryoport plays an important role in NBS20 development by supporting the Intus Study with the cryopreserved delivery of NBS20 to our clinical sites in the United States.  They have been instrumental in facilitating trial access to our patients and we welcome the opportunity to further strengthen and expand our relationship with the company as we require additional support."

Jerrell Shelton, Chief Executive Officer of Cryoport, stated, "We are pleased to be able to support NeoStem with their efforts in developing innovative cell-based personalized therapies.  Our validated cryogenic logistics solutions will maintain the integrity of the Intus trial as it advances through the regulatory pathway that has been set by the FDA.  We are actively supporting the distribution of NBS20 and will eagerly continue to support NeoStem as it advances its clinical trials."

NEW YORK, April 27, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today that the European Medicines Agency (EMA) has classified the Company's lead immuno-oncology product candidate, NBS20, as an Advanced Therapeutic Medicinal Product (ATMP). ATMP classification, which is approved by the Committee for Advanced Therapies (CAT), was established to regulate cell and gene therapy and tissue engineered medicinal products, support development of these products and provide a benchmark for the level of quality compliance for pharmaceutical practices. As a designated ATMP product, NBS20 would follow the Centralized Procedure through the European Medicines Agency and benefit from a single evaluation and authorization process. Additional benefits established through the ATMP regulation include pathways for Scientific Advice and significant fee reductions for such advice.

NBS20 is the Company's patient-specific targeted cancer immunotherapy candidate being investigated in the Intus Phase 3 trial in patients with stage III recurrent or stage IV metastatic melanoma. Treatment of metastatic melanoma continues to be an unmet medical need globally. In Europe, over 20,000 deaths from melanoma were estimated in 2008, approximately twice the number of recent estimates of annual deaths in the US.

NeoStem's global Intus trial has been granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA). In addition, NBS20 has US Orphan Drug and Fast Track designations by FDA. Patient screening began in the first quarter of 2015 and the Company anticipates the randomization of the first patient in the Intus trial in the second quarter of 2015.

"We thank the EMA for this validation of the technically advanced nature of NBS20 as a therapy for melanoma. The ATMP classification will facilitate discussions with EMA as part of our strategy to seek product registration in the EU," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem. "This designation sets NBS20 apart from the immunologic approaches being developed to treat melanoma based on inhibition of a single target and emphasizes its ability to address the complex and multiple tumor-specific targets found on each patient's metastatic tumors."

NEW YORK, April 20, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today the expansion of manufacturing services under an existing Services Agreement between its wholly-owned subsidiary, PCT, and Kite Pharma, Inc. (KITE) (Kite), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer.

Under the terms of the original agreement, PCT and its center of excellence for cell therapy process development, engineering and manufacturing, provided development and manufacturing services for Kite's lead eACT(TM) clinical development program. These services included technology transfer, process development, qualification and implementation of the manufacturing process. Under the expanded Services Agreement, Kite will receive these services through increased facilities and personnel at PCT's Mountain View, CA location that are contractually dedicated to Kite.

"We look forward to continuing our mutually beneficial partnership with Kite and to offering manufacturing service for the important cell therapy that they plan to advance toward the commercial market," said Dr. Robert A. Preti, Chief Scientific Officer of NeoStem and President of PCT. "The expansion of NeoStem's arrangement with Kite allows us to grow our Mountain View facility and to continue providing innovative, reliable and high quality manufacturing expertise to cell therapy developers who are researching potentially life-changing treatments for patients across many therapeutic areas."

"We are pleased that we have expanded our relationship with Kite and look forward to continuing to provide them with premium specialized immunotherapy manufacturing services. This arrangement with Kite will serve as a model for future collaborations between PCT and its clients," said Dr. David J. Mazzo, NeoStem's Chief Executive Officer. "We have valued PCT's expertise, manufacturing facilities, and services, and we look forward to a continued productive relationship with them," said Dr. Arie Belldegrun, Chairman, President and Chief Executive Officer of Kite.

NEW YORK, April 9, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell based personalized medicine therapies, announced today the extension of its study under a 2014 Early Translational grant from the California Institute of Regenerative Medicine for research leading to the development of a treatment for retinal diseases, including macular degeneration and retinitis pigmentosa.

Under the $4 million grant made to the University of California, Irvine, NeoStem is entitled, through a subaward, to $1 million of new funds adding to the original $0.5 million awarded. The goals of the research are to generate three-dimensional retinal tissue, to investigate the ability of adult induced pluripotent stem cells to restore sight in rodent models of retinal degeneration and to make eventual preparations for clinical use of the tissue.

The grant supports a three-year study led by Dr. Hans S. Keirstead, President of NeoStem Oncology, and Dr. Magdalene J. Seiler, Project Scientist V at the University of California, Irvine and its Sue & Bill Gross Stem Cell Research Center.

"This study exemplifies our commitment to utilizing non-dilutive funding sources for discovery programs exploring application of our technologies in other indications. A self-sustaining development pipeline depends on the generation of new development programs that are reasonable in terms of size of opportunity and clinical investment," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem.

In the first year of the study, NeoStem fulfilled its primary goal of reproducibly generating retinal pigment epithelium (RPE) and layered retinal progenitor tissue, which include progenitors of the major retinal cell types including photoreceptors. This success enables the rest of the study, which will focus on transplantation and testing of these tissues in rodent models of retinal degeneration.

Approximately 11 million people in the United States have some form of age-related macular degeneration. This number is expected to double to nearly 22 million by 2050. Estimates of the global cost of visual impairment due to age-related macular degeneration is $343 billion, including $255 billion in direct health care costs.

Item 7.01 Regulation FD Disclosure. 
   

On Monday, March 16, 2015, NeoStem, Inc., a Delaware corporation (the “Company” or “NeoStem”), issued a press release announcing that updated efficacy and safety results from the one-year follow-up for its Phase 2 PreSERVE AMI study and additional analyses of certain functional tests were presented at ACC.15, the American College of Cardiology’s 64th Annual Scientific Session and Expo, in San Diego, California. A copy of the press release is attached hereto as Exhibit 99.1. The data as presented by Dr. Arshed A. Quyyumi, the Lead Principal Investigator of our PreSERVE AMI Study, at the ACC Expo, is also attached hereto as Exhibit 99.2.

Additionally, NeoStem intends, from time to time, to present and/or distribute to the investment community and utilize at various industry and other conferences a slide presentation. The slide presentation is accessible on NeoStem’s website at www.neostem.com and is attached hereto as Exhibit 99.3. NeoStem undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.3.
   
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, 99.2 and 99.3, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing.

NEW YORK, March 16, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell based personalized medicine therapies, announced today the presentation of updated efficacy and safety results from the one-year follow-up for its Phase 2 PreSERVE study and additional analyses of certain functional tests at ACC.15, the American College of Cardiology's 64th Annual Scientific Session and Expo, in San Diego, California. The one-year follow-up results are defined as all data accumulated until the last patient enrolled completed 12 month follow-up. Thus, the results actually represent data from patients with a median follow-up of 18 months.

The PreSERVE study is NeoStem's clinical trial evaluating NBS10 which is being developed to treat damaged heart muscle following an acute myocardial infarction. One-year follow-up safety data collected thus far supports the trial's 6 month results presented at the American Heart Association's Scientific Sessions in November 2014. The ACC presentation contained updated safety and exploratory efficacy data and additional analyses conducted on left ventricular ejection fraction (LVEF) data. Clinical Endpoint Committee adjudication of major adverse cardiac events (MACE) was performed on the 6 month data reported previously and was not performed for new events (occurring between 6 and 12 months). The next prescribed adjudication of MACE is currently planned at the end of patient follow-up. At 12-month follow-up, no meaningful safety or tolerance differences were observed between treatment and control groups. In this updated analysis, no additional deaths were reported in the treatment or control groups beyond those previously reported in the six month analysis. In addition, in post hoc subset analyses based on the number of cells patients received, serious adverse event (SAE) frequency continues to show numerical improvement at all cell doses when compared to control.

No additional SPECT data were collected at one year follow-up. As an exploratory measure of efficacy, PreSERVE looked at reduction of infarct size at six months. Patients receiving 20 million cells or more experienced a decrease in infarct size of 41% vs 24% for patients in the control group.

Based on the one-year follow-up results, the company and its scientific advisors believe that the study results suggest:

• Intracoronary administration of autologous CD34+ cells appears safe and well-tolerated;
• A signal for a mortality benefit; and
• A signal for reduction in the frequency of serious adverse events (SAEs) in higher dose groups.

"We believe that these data, when coupled with the six month data on MACE and LVEF that we previously reported, are encouraging and show the possibility that higher doses of CD34 cells may provide benefit to patients post-STEMI," said Dr. Douglas Losordo, Chief Medical Officer of NeoStem. "Further consideration of these data, in consultation with our medical advisory board, should lead us to a determination of the next steps for the development of this program in the second half of 2015."

"While small in number, we are encouraged by the fewer mortality events observed for treated patients versus control patients as of the date of this 12 month follow-up. In addition, we are very encouraged by the persistence of reduced serious adverse event rates and evidence for improved infarct healing and left ventricular function," said Dr. Arshed A. Quyyumi, Professor of Medicine at Emory University and Lead Principal Investigator of the PreSERVE AMI study, who made the presentation at ACC.15. "In addition, the failure of SPECT imaging to document changes at the 6 month interim analysis, despite signs of clinical benefit in multiple parameters, suggests that this technique is not applicable in this setting."

NEW YORK, March 2, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS) ("NeoStem" or the "Company"), a biopharmaceutical company developing novel, cell-based personalized medicine therapies, announced today 2014 year end results and provided an update on its business.

"We are pleased with our company's achievements in 2014 and look forward to reporting on our progress advancing the programs in our diversified and balanced pipeline," said Dr. David J. Mazzo, Chief Executive Officer of NeoStem. "Our near-term focus will be the initiation of and continued enrollment in our Phase 3 Intus Study for stage III recurrent and stage IV metastatic melanoma patients. This is a program supported by Special Protocol Assessment as well as Fast Track and Orphan Designations. We expect the first patient randomization for the study in the second quarter of 2015. We also are planning the release of one-year data from the PreSERVE Phase 2 trial for acute myocardial infarction on March 15, 2015 at the Annual Scientific Sessions of the American College of Cardiology. We expect that these results will further corroborate the results observed at 6 months of a clinically meaningful effect of our NBS10 candidate."

Business Highlights

Over the past year, NeoStem significantly advanced its leadership in the cell therapy industry, with highlights including:

• The acquisition of California Stem Cell, Inc., (CSC) and execution of the steps necessary to initiate a pivotal Phase 3 trial for its most advanced product candidate, NBS20 (USAN generic name of eltrapuldencel-T, an autologous melanoma-initiating cell immune-based therapy intended to eliminate the tumor cells capable of causing disease recurrence) in recurrent stage III and stage IV metastatic melanoma patients;
• Announcement of clinically meaningful six-month primary analysis results from the Company's Phase 2 PreSERVE study for patients with left ventricular dysfunction post-ST elevation myocardial infarction (STEMI);
• Announcement of Phase 1 results for a T regulatory cell immunotherapy for type 1 diabetes, which included preliminary data indicating safety and tolerability in adult patients, complementing recently published 12-month data indicating feasibility and potential efficacy in children with type 1 diabetes;
• Strengthening of executive management with appointments of David J. Mazzo, PhD as Chief Executive Officer and Robert S. Vaters as President and Chief Financial Officer;
• Announcement of agreement with Invetech Pty Ltd. to develop a closed-processing system for cell therapy manufacturing, to provide a flexible small-scale process suitable for GMP manufacturing of autologous and other patient-specific products where small-scale is full scale, while also supporting efficient development of processes at lower cost prior to transitioning to scaled volumes.

2014 Year-End Financial Highlights

Total revenue for the year was $17.9 million compared to $14.7 million in 2013, an increase of 22%. Clinical Services, representing process development and clinical manufacturing services provided at PCT (NeoStem's wholly-owned subsidiary, a contract development and manufacturing organization) to its various clients, were approximately $10.4 million for 2014 compared to $9.1 million for 2013, representing an increase of approximately $1.3 million or 14%.

Research and development expenses were approximately $29.2 million for 2014 compared to $16.9 million for 2013. The increase was primarily comprised of investment in the Company's (i) targeted cancer immunotherapy program, including the initiation of the Intus Phase 3 clinical trial for the Company's lead cancer immunotherapy product candidate NBS20, (ii) ischemic repair program, including expenses associated with the PreSERVE AMI Phase 2 clinical trial for the Company's product candidate NBS10, and (iii) immune modulation program, primarily due to the Company's efforts to develop Tregs.

Selling, general and administrative expenses were approximately $30.8 million for 2014 compared to $21.6 million for 2013. The increase was related to increased corporate development activities, expenses associated with the additional California Stem Cell (CSC) operating activities since its acquisition in May 2014, and increased corporate infrastructure needed to support the Company's expanded clinical activities. In addition, the increase was related to higher equity-based compensation paid in exchange for services and, in particular, equity awards issued as a bonus for the successful completion of the CSC acquisition.

Net loss for 2014 was $55.5 million compared with a $39.5 million loss for 2013. Net loss for 2014 excluding non-cash charges was $45.2 million, compared with $28.7 million for 2013 (see below for reconciliation).

At December 31, 2014 NeoStem's cash, cash equivalents and marketable securities totaled $26.3 million.

2015 Outlook

In 2015, NeoStem's management expects significant additional achievements. The Company's milestones and goals for the year include:

NEW YORK and SAN DIEGO, Jan. 12, 2015 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a leader in the development and manufacturing of cell therapy products and regenerative medicine, and Invetech Pty Ltd ("Invetech"), a global leader in instrument development, custom automation and contract manufacturing, today announced an agreement for the development of a new closed processing system (the "System") for cell therapy manufacturing. Under the agreement, Invetech will provide system design and engineering development and NeoStem will develop applications for performing closed cell processing manipulations such as separation. The agreement envisions NeoStem as the commercial supplier of the System which would constitute its first branded entry into the cell therapy tools market.

The System will be applicable to a range of cell therapy processes in development and commercialization stages, and will consist of an instrumentation platform, disposable flow path, and operating and application software for automated execution of user-selected protocols. The System will provide a flexible small scale process suitable for GMP manufacturing of autologous and other patient-specific products where small scale is full scale, while also supporting efficient development of processes at lower cost prior to transitioning to scaled volumes.

"We are pleased to be partnering with Invetech on the development of a new technology specifically designed to meet the needs of our clients as their cell therapy products progress through clinical trials on a path towards commercialization," said Robert A. Preti, Ph.D., president of PCT, and chief scientific officer of NeoStem. PCT will carry out the work and is a wholly-owned subsidiary of NeoStem.. "By combining PCT's more than 15 years of process development and manufacturing experience with Invetech's industry leading automated processing device expertise, we hope to produce and potentially market a system that would deliver significant cost of goods, quality, and scaling benefits over existing manual, cleanroom-based processing strategies."

"Working with NeoStem to create equipment that will deliver services to companies in the emerging cell therapy industry is exciting and satisfying," said Richard Grant, global vice president, cell therapy division of Invetech. "Our team shares a common passion with NeoStem to grow the cell therapy industry by developing new technology to support successful product development and commercialization."

"NeoStem's Engineering and Innovation Center (EIC) is one of the first dedicated centers responding directly to the major challenges that are facing the manufacturers of cell based therapeutics," said Brian Hampson, vice president, manufacturing development and engineering. "If ultimately commercialized, the sale of disposables associated with the System, especially for patient-specific therapies where one disposable set is used per patient, could potentially become a meaningful revenue area for NeoStem."

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
 

Appointment of Executive Chairman, Chief Executive Officer and President & Chief Financial Officer

Effective January 5, 2015 (the “Commencement Date”), the board of directors (the “Board”) of NeoStem, Inc. (the “Company”) appointed Robin L. Smith, M.D., the Company’s Chief Executive Officer and Chairman of the Board since 2006, as the Company’s Executive Chairman of the Board.

Also effective on the Commencement Date, the Board appointed David J. Mazzo, Ph.D. as the Company’s new Chief Executive Officer and simultaneously appointed him to the Board as a Class II director with an initial term expiring at the Company’s 2015 annual meeting of stockholders, and appointed Robert S. Vaters as the Company’s new President and Chief Financial Officer. On the Commencement Date, Mr. Dickey is no longer serving in his prior capacity of Chief Financial Officer.

NEW YORK, Dec. 15, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell based therapeutics, and Progenitor Cell Therapy, LLC ("PCT"), a NeoStem company and a leading contract development and manufacturing organization in the cellular therapy industry, announced that Dr. Ian Gaudet, Senior Engineer with PCT's Engineering and Innovation Center, presented results of PCT's most recent study to generate data on the performance of the Lovo(R) Cell Processing System.

Dr. Gaudet presented the results on December 12, 2014 at IBC Life Sciences' Commercialization of Cell, Gene & Immunotherapies conference in San Diego, California.

The Lovo cell processor, developed and sold by Fresenius Kabi, is an automated system that removes supernatant from target cells and stores them in viable media. Lovo automates the labor-intensive tasks of separation, washing, platelet-reduction, fluid-exchange, and concentration of white blood cells. The system includes single-use disposable processing sets with a sterile fluid path to facilitate closed system processing.

Fresenius Kabi introduced the Lovo system at the 20th Annual International Society for Cell Therapy meeting held in Paris, France in April 2014. The system is designed for use in research and transplant laboratories in academic institutions, biotech companies and other facilities that process cells.

Utilizing its more than 15 years of cell processing expertise, PCT has been evaluating the use of the Lovo system in typical cell therapy applications and generating data on the operation, performance, and usability of the device. Study results presented at IBC indicate performance advantages of the Lovo system in comparison to other methods for cell washing and volume reduction, including high cell recovery, maintenance of cell viability, and effective reduction of pre-wash ingredients. The Lovo system also provided operational advantages, including closed, fully automated execution of the process. The data was generated for washing two liters of culture-expanded T cells into a final volume of 150 mL, a typical need for cellular immunotherapy applications. The study took place in PCT's Mountain View, California facility.

"Current and future users of the Lovo system now have additional feedback and data from an end-user perspective," said Dr. Robert A. Preti, President of PCT and Chief Scientific Officer of NeoStem. "Our team has gathered firsthand experience with this major product offering in cell therapy � experience that will ultimately benefit our clients who use the Lovo system. Data gathered from this evaluation will help the industry respond to some of the unique challenges that are facing cell therapy manufacturers today."

PCT's collaboration in support of the Lovo system is one of the initiatives being undertaken by PCT's recently formed Engineering & Innovation Center (EIC), designed to help PCT's client base accelerate the development of more cost effective and robust manufacturing processes for cellular therapeutic candidates. Through the EIC, PCT helps its clients think beyond current practices and accelerate the use of automation, integration and other engineering strategies to address important issues such as scale up and cost of goods in anticipation of commercial production.

"We are pleased to apply the expertise and resources of our Engineering and Innovation Center to continue to better understand the current and influence the future technology landscapes for manufacturing development in regenerative medicine," said Brian Hampson, Vice President, Manufacturing Development and Engineering of PCT. "The data gathered from this evaluation may help a wide variety of cell therapy companies respond to some of the challenges they are facing today. The ability of customers to achieve robust processing on a closed, automated platform like the Lovo system, should help them achieve faster, easier and more consistent results in their cell processing."

ALLENDALE, N.J., Dec. 8, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS) ("NeoStem" or the "Company"), a biopharmaceutical company developing novel cell based therapeutics, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced today that PCT has been awarded re-accreditation by AABB (formerly known as the American Association of Blood Banks) in the category of "Cell Therapy Activity: Cord Blood -- Processing, Storage and Distribution" for its Allendale, NJ facility. Accreditation follows an intensive on-site assessment by specially trained AABB assessors and establishes that the level of technical and administrative performance within the facility meets or exceeds the standards set by AABB.

"PCT continues to offer high-quality manufacturing services and expertise to cell therapy clients, and the AABB accreditation is a testament to the safety and high standards at its Allendale facility that clients have come to expect," said Dr. Robin Smith, Chief Executive Officer of NeoStem.

AABB's Accreditation Program contributes to the quality and safety of collecting, processing, testing, distributing and administering blood and cellular therapy products. The Accreditation Program assesses the quality and operational systems in place within a facility. The basis for assessment includes compliance with AABB Standards, Code of Federal Regulations and federal guidance documents.

PCT originally announced that it had earned AABB accreditation in April 2011, when it also announced FACT accreditation for its Allendale facility. FACT-JACIE standards were developed in 2006 by the Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT). AABB has been a leader in the development of standards for voluntary compliance since 1957, when the first edition of Standards for Blood Banks and Transfusion Services was published.

"We are pleased that this AABB reaccreditation serves as a reaffirmation of PCT's continued dedication to safety and compliance as we continue to work towards commercial scale manufacturing capabilities while providing high quality, reliable service to all of our clients," said Robert A. Preti, Ph.D., PCT's President and Chief Scientific Officer.

NEW YORK, Nov. 21, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a biopharmaceutical company developing novel cell based therapeutics, announced on November 17^th initial positive data from its 161 patient Phase 2 PreSERVE AMI (or acute myocardial infarction) clinical trial.

NeoStem is sharing additional information to clarify certain facts regarding the Phase 2 PreSERVE trial as "we are extremely disappointed, in the face of exciting results, that shareholder value is being diminished by pervasive inaccurate or incomplete statements about the study," said Dr. Robin Smith, Chairman and CEO of NeoStem.

By way of background, the goal of a phase 2 trial is to continue to build evidence of the safety and feasibility of the product candidate and to gather evidence of bioactivity and potential efficacy. Ultimately, the hope for a phase 2 study is that it yields information that can guide the design of the next phase study and NeoStem believes this has been achieved.

The original phase 2 primary endpoints were an imaging endpoint that was designed to provide evidence of changes in blood flow and a safety endpoint that was limited to the bone marrow harvest and infusion period.

Prior to data lock, NeoStem elected to revise its primary safety endpoint to include a comprehensive assessment of safety including all adverse events, serious adverse events and MACE. This decision was made after consultation with the Food and Drug Administration ("FDA") and based on:

1) Published FDA guidance regarding the preferred endpoints for approval of cell therapies for acute myocardial (e.g. mortality, hospitalizations);

2) Emerging scientific literature showing a dose-dependent benefit of cell therapies in terms of reduced major adverse cardiac events (MACE).

Accordingly, by cover letter dated July 14, 2014 NeoStem filed with the FDA an amendment of its protocol entitled "A Prospective Randomized Double Blinded Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34⁺ selected Cell Product, in Patients with Acute Myocardial Infarction" (v.9.0).

The letter references (i) the telephone conversation on July 1, 2014 between Company personnel and the FDA regarding the protocol and statistical analysis plan ("SAP"); (ii) the email communication between Company personnel and the FDA on July 1, 2014 to seek FDA concurrence on the changes to the protocol and the SAP, and (iii) the telephone conversation between Company personnel and the FDA on July 8, 2014. The letter reads verbatim and in pertinent part:

The key changes to the protocol and SAP include:

1. The order of endpoints was changed, with MACE moved from a secondary endpoint to the primary safety endpoint. It replaces the assessment that was previously focused solely on risks of the harvest and infusion to this outcome that we believe provides a broader and more useful view of overall safety. In the revised protocol and SAP, this measure is listed both as primary safety and as a secondary efficacy endpoint. The data regarding the safety of bone marrow harvest and infusion will be included in this analysis.
   
2. Previously, we proposed to conduct the primary analyses based on data through each patient's Month 6 visit, which is the time when the primary imaging outcome is assessed. However, doing so meant that we would potentially report on clinical effects using only a fraction of the available data. Therefore, we now propose to analyze the clinical effects of this therapy in all patients through the time of the last patient's Month 6 visit. This will markedly increase the observation period and therefore provide more power to draw inferences and conclusions about the clinical impact of this therapy, important in planning phase 3. With the submission we will include the Clinical Endpoint Committee Charter.
   
3. While the safety analyses continue to focus on the ITT population, we changed the efficacy population of highest interest to the Per Protocol population, defined as those patients who received full dose of the investigational product and underwent SPECT imaging both at baseline and Month 6. With the goal of the study to evaluate the bioactivity of the therapy to affect myocardial perfusion, we felt that this population would be most critical to making this determination. Analyses of the ITT and mITT populations will also be performed.
   
4. The MACE endpoint previously included cardiovascular death, heart failure hospitalizations and reinfarctions. Based on the literature suggesting potential impact on revascularization rates, we changed the MACE endpoint to include all coronary revascularizations.

Again, the Company's decision to expand the primary endpoints was done prior to the Contract Research Organization (CRO), which holds all data related to the study, locking the database and performing the initial analysis.

Highlights of the initial results include:

• A statistically significant mortality benefit (p<0.05) in patients treated with NBS10 (also known as AMR-001) as compared to the placebo group; there were no deaths in the treatment group.
  
• A statistically significant dose-dependent reduction in SAEs (p<0.05).
  
• Observation of a dose-dependent numerical decrease in MACE. MACE occurred in 14% of control subjects, in 17% of subjects of who received less than 14 million CD34 cells, in 10% of subjects who received greater than 14 million CD34 cells, and in 7% of subjects who received greater than 20 million CD34 cells.
  
• When correcting for the time to stent implantation in all subjects, patients treated with CD34 cells were seen to have a statistically significant dose-dependent improvement in their ejection fraction (p<0.05). Independent from time to stent implantation, a statistically significant improvement in ejection fraction (p<0.05) for patients treated with a dose of greater than 20 million CD34 cells compared to placebo was observed.
  
• No meaningful difference in perfusion, as evidenced by SPECT imaging, between the treatment and the control group from baseline to 6 months in resting total severity score (RTSS) suggesting this may not be a future suitable tool to assess NBS10, which is consistent with U.S. Food and Drug Administration (FDA) guidance that mortality and MACE are the appropriate approvable endpoints to determine efficacy of a cellular therapy for cardiac disease as opposed to imaging endpoints.

"For cardiologists, our key goal is to keep patients from progressing to worsening heart muscle function and death after a major heart attack," said Dr. Arshed A. Quyyumi, Professor of Medicine at Emory University and Lead Principal Investigator of the PreSERVE AMI study. "It is encouraging to see clinically meaningful results this early in the study, and I look forward to future data readouts."

Interestingly, prior to trial enrollment, patients subsequently randomized to the treatment group had experienced a significantly longer time to stent implantation after the onset of symptoms (931 minutes) compared to subjects subsequently randomized to the control group (569 minutes). This longer interval to reperfusion would ordinarily be expected to be associated with worse clinical outcomes.*

Further supporting the potential efficacy of this product candidate, the results provide evidence that the positive effects observed were due to intracoronary administration of NBS10, and not endogenous CD34 cells. There was no relationship between high bone marrow CD34 cell counts and improvements in MACE, mortality, or ejection fraction in the control group.

"Similar to what was seen in Phase 1, we have observed a relationship between the dose of CD34 cells administered and a positive effect on cardiac function. In our current trial, in addition to improved cardiac function, a CD34 dose-related reduction in serious adverse events was observed, highlighting the potential for clinical benefit," said Dr. Andrew Pecora, Director and Chief Visionary Officer of NeoStem and co-inventor of the core technology upon which NeoStem's Ischemic Repair Program is based.

Dr. Douglas W. Losordo, Chief Medical Officer of NeoStem, stated that, "the demonstration by this study of a statistically significant reduction in mortality and a dose-dependent reduction in overall MACE in treated subjects provides us important direction as we move towards designing a pivotal trial that is consistent with FDA guidance."

NeoStem's subsidiary, PCT (Progenitor Cell Therapy), a leading contract development and manufacturing organization in the cellular therapy industry, developed the manufacturing process for NBS10, and has provided all of the manufacturing of product for both its Phase 1 and Phase 2 trials. Over the last two years, PCT has worked to further optimize the yield of CD34 cells in order to maximize the dose that can be delivered to patients.

"By refining the methods for collecting and purifying CD34 cells for the PreSERVE AMI trial, we believe that we can facilitate providing doses of a sufficient number of CD34 cells for most patients from a single harvest," said Dr. Robert Preti, NeoStem's Chief Scientific Officer, President of PCT, and co-inventor of the core technology upon which NeoStem's Ischemic Repair Program is based. "The Engineering and Innovation Center at PCT continues to refine the process to provide for high quality, scalable and sustainable manufacturing at an optimal cost of goods for wide-scale commercial production."

Patients with AMI are at significant risk of downstream adverse events, including chronic heart failure, recurrent AMI, significant arrhythmias, premature death or acute coronary syndrome. A report from Agency for Healthcare Research and Quality (2011) surveyed the most expensive hospitalization conditions by payor, and lists AMI as the sixth most expensive condition treated in U.S. hospitals, with a national hospital bill of more than $37 billion annually.

"Heart attacks and cardiovascular disease are a significant physical and economic burden on society, and it is encouraging to see what we believe to be a meaningful impact on patient outcomes at this early point in the trial," said Dr. Robin Smith, Chairman and CEO of NeoStem. "While perfusion is important in the pathophysiology of a damaged heart, SPECT imaging may not be sensitive enough to measure differences. Additionally, the FDA has taken the position that such analysis should not be relied upon as an "approvable" endpoint for a cellular therapy for cardiac disease. As we continue to develop NBS10, we will continue to consult with the FDA, external advisors and future partners to determine the best path forward for the future."

 Third Quarter of 2014 Financial Results

• Total revenue for the three months ended September 30, 2014 was $4.1 million, up 11% percent from $3.7 million for the prior year period.
• Basic and diluted loss per share attributable to NeoStem, Inc. was (0.48) vs last years same quarter of (0.45).

"We look forward to reaching these important clinical milestones in our ischemic repair and targeted cancer immunotherapy programs and are pleased that this achievement is being enabled by our unique ability to leverage the expertise of our subsidiary, PCT, recognized as a world leader in providing high quality manufacturing capabilities, support and innovative engineering solutions to developers of cell based therapies," said Dr. Robin Smith, Chairman and CEO of NeoStem.

BOTHELL, Wash., Oct. 14, 2014 /PRNewswire/ -- BioLife Solutions, Inc. (BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues  ("BioLife" or the "Company"), today provided an update on use of the Company's HypoThermosol storage/shipping media and CryoStor cryopreservation freeze media by Progenitor Cell Therapy, LLC (PCT), a wholly owned subsidiary of NeoStem, Inc., (NBS) a leader in the emerging cellular therapy field.

PCT is an internationally recognized contract development and manufacturing organization (CDMO) focused on providing exceptional service, quality and value to its regenerative medicine clients, which include an expanding range of development stage organizations, Fortune 500 biotechnology, pharmaceutical and medical product companies, as well as leading academic research institutions. PCT operates two state-of-the-art, accredited and certified U.S. facilities, one in Allendale, New Jersey and the other in Mountain View, California. 

Robert A. Preti, PhD, President & Chief Scientific Officer at PCT, commented on the use of BioLife products by stating, "Two critical commercialization challenges for novel cell and tissue-based products stem from limited shelf life and poor quality following preservation.  Over the last several years we have evaluated many custom formulations and commercial preservation media products for storage, shipping, freezing, and administering cell-based biologics in clinical applications.  The biopreservation efficacy of BioLife's clinical grade HypoThermosol and CryoStor is very impressive.  There is a high degree of awareness of these products in the field and we use BioLife products in several of our current cell therapy development projects, including some of NeoStem's clinical product candidates along with many programs for mutual customers of BioLife and PCT."

A 2013 visiongain Translational Regenerative Medicine market research report forecasts that the regenerative medicine market comprised of cell and gene therapies and tissue-engineered products will grow to more than $23 billion by 2024. BioLife estimates that the Company's biopreservation media products are now incorporated into the collection, storage, shipping, freezing, and/or patient administration processes of at least 130 customer clinical trials or novel cell-based regenerative medicine products and therapies. 

Mike Rice, BioLife President & CEO, stated, "The use of HypoThermosol and CryoStor at PCT is further validation of the value our proprietary biopreservation media products provide to the high growth regenerative medicine market.  PCT is a very high quality contract development and manufacturing services provider and we recognize the scrutiny with which they evaluated our products, leading to adoption and use in multiple projects, both internal and for mutual customers.  We look forward to continuing and strengthening our relationship with PCT."

NEW YORK, Oct. 6, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a leader in the emerging cellular therapy industry, announced today that the United States Adopted Name Council (USAN) has approved the generic name "eltrapuldencel-T" for the Company's patient-specific targeted cancer immunotherapy under investigation for the treatment of Stage IV or recurrent Stage III metastatic melanoma. This investigational treatment, planned to be evaluated in the Company's Phase 3 Intus study, has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and will be conducted under a protocol that has been granted Special Protocol Assessment ("SPA"). NeoStem plans to begin the trial by the end of 2014.

Eltrapuldencel-T is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence and progression. Creation of the therapy begins with cancer initiating (stem) cells that have been isolated from the patient's resected tumor sample, enriched and inactivated. These newly created cancer initiating (stem) cells are then combined with dendritic cells (antigen-presenting immune cells) derived from the patient's own blood, and granulocyte-macrophage colony stimulating factor (GM-CSF, a natural growth factor that stimulates white blood cells in the body). The product is then introduced back into the patient via a series of subcutaneous injections.

"We welcome the receipt from USAN of the generic name for use in this important program and look forward to the launch of our pivotal Phase 3 trial to evaluate eltrapuldencel-T," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

Eltrapuldencel-T was developed by recent NeoStem acquisition California Stem Cell, Inc., based on a technology developed over the course of 10 years at Hoag Memorial Hospital Presbyterian in Newport Beach, California. Two previous Phase 2 clinical studies conducted at Hoag had resulted in a combined median 5-year survival of 50% in patients with Stage IV melanoma, double that of any current treatment.

Following on the success of those trials, the Intus study is a multi-national randomized, double-blind Phase 3 clinical trial in which patients will be randomized in a 2:1 ratio to receive either eltrapuldencel-T or a control treatment (autologous mononuclear cells in GM-CSF). An expected 250 enrolled patients throughout the U.S., Canada, Australia and New Zealand will receive weekly injections for three consecutive weeks, and then once monthly for five months.

NEW YORK, Oct. 1, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. ("NeoStem" or the "Company," Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today its establishment of a melanoma scientific advisory board consisting of internationally renowned experts in oncology and in the development of novel therapeutics for melanoma. The group of six experts, including medical oncologists, a basic scientist, and a surgical oncologist specializing in melanoma, will advise and provide support to NeoStem in the area of melanoma research and clinical development. Each of the consultants contributes a breadth of experience in the oncology field intended to enable the successful design and execution of the Company's upcoming Intus Phase 3 clinical trial investigating the use of its DC/TC (dendritic cell/tumor cell) technology in patients with metastatic melanoma.

The members of this advisory board include:

• Michael B. Atkins, M.D., of the Georgetown-Lombardi Comprehensive Cancer Center in Washington D.C.;
• Lisa H. Butterfield, Ph.D., of the University of Pittsburgh in Pittsburgh, Pennsylvania;
• Kim Margolin, M.D, of Stanford University in Palo Alto, California;
• Steven J. O'Day, M.D., of the Beverly Hills Cancer Center in Beverly Hills, California;
• Merrick I. Ross, M.D., of the University of Texas M.D. Anderson Cancer Center in Houston, Texas;
• Jedd D. Wolchok, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center in New York City

"This impressive group of physicians and researchers will serve as an excellent source of external input in areas such as clinical strategy, anticipated trends in the management of melanoma and medical practice, identification of other opinion leaders in the field, and correlative studies, such as sensitive assays for detecting the extent of anti-tumor response," said Dr. Robert Dillman, Vice President of Oncology of NeoStem.

"With our Intus Phase 3 melanoma clinical trial investigating the use of our DC/TC technology expected to begin by year's end, we are thrilled to be receiving the guidance of such notable specialists," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "Their collective experience in melanoma research and the clinical development of cancer immunotherapies will be invaluable as we move forward the development of this therapy."

The Company's DC/TC (dendritic cell/tumor cell) product candidate is an autologous immunotherapy intended to eliminate cancer-initiating (stem) cells capable of causing disease recurrence. The therapy employs the patient's own tumor cells and dendritic cells (a type of immune cell), along with granulocyte-macrophage colony stimulating factor (GM-CSF, a natural growth factor that stimulates white blood cells in the body). The patient's dendritic cells are mixed with the patient's tumor cells to create the therapeutic agent, which is then suspended in GM-CSF for injection into the patient. DC/TC was developed by California Stem Cell, Inc., which was acquired by NeoStem in May 2014. NeoStem plans to begin the Intus study of DC/TC later this year and has been granted fast track and orphan designation by the Food and Drug Administration ("FDA"). The trial has a Phase 3 protocol that is the subject of a Special Protocol Assessment ("SPA").

NEW YORK, Sept. 29, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, announced today that it has entered into a Loan and Security Agreement (the "Loan Agreement") with Oxford Finance LLC ("Oxford") pursuant to which Oxford has agreed to make a term loan to the Company in the principal amount of up to $20 million, and has made the initial disbursement of $15 million. The loan matures in September 2018 and the additional $5 million disbursement is available in the event of the Company's consummation of a partnering transaction around the Company's NBS10 development program for post acute myocardial infarction ("AMI") patients. Oxford will have a security interest in substantially all the Company's real and personal property, excluding intellectual property. No warrants or common stock were issued in connection with this financing.

"This new debt facility will serve as an excellent source of non-dilutive capital to support the launch of our Intus Phase 3 clinical trial in metastatic melanoma, a significant milestone we anticipate meeting by the end of this year," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We are pleased both by the terms of the loan and the flexibility it offers us to meet our near-term goals."

WBB Securities, LLC acted as a financial advisor to NeoStem on the transaction.

NeoStem is on track to present data from its PreSERVE AMI study at the American Heart Association's Scientific Sessions on November 17, 2014. PreSERVE AMI is a randomized, double-blinded, placebo-controlled Phase 2 clinical trial testing NBS10, an autologous (donor and recipient are the same) adult stem cell product for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction ("STEMI").

The Company plans to begin the Intus Study, its Phase 3 clinical trial to evaluate the lead product candidate in its targeted immunotherapy program for cancer, NBS20, as an autologous treatment for patients with Stage IV or recurrent Stage III metastatic melanoma, by the end of 2014. NBS20, also referred to as DC/TC (dendritic cell/tumor cell), targets malignant melanoma initiating cells, has been granted fast track and orphan designation by the Food and Drug Administration ("FDA"), and has a Phase 3 protocol that is the subject of a Special Protocol Assessment ("SPA"). The SPA indicates that the FDA is in agreement with the design, clinical endpoints, and planned clinical analyses of the Phase 3 trial that would serve as the basis for a Biologics License Application ("BLA") that would be filed with the FDA requesting marketing approval of this therapeutic candidate.

Item 1.01.                Entry into a Material Definitive Agreement.
 

On September 26, 2014, NeoStem, Inc. and its subsidiaries (collectively, the “Company”) entered into a loan and security agreement (the “Loan and Security Agreement”) with Oxford Finance LLC (together with its successors and assigns, the “Lender”) pursuant to which the Lender has agreed to lend the Company up to $20,000,000. Upon entering into the Loan and Security Agreement, the Lender disbursed $15,000,000 (“Term Loan A”). Under the terms of the Loan and Security Agreement, during the Second Draw Period, the Company may, subject to certain conditions, borrow from Lender an additional $5,000,000 (“Term Loan B”, together with Term Loan A, the “Term Loans”). The “Second Draw Period” is the period of time: (a) commencing on the date that Lender receives evidence in a form and substance satisfactory to Lender that the Company has entered into a strategic arrangement in a form and substance acceptable to Lender with respect to NeoStem, Inc.’s NBS10 (also referred to as AMR-001) drug for ST Elevation Myocardial Infarction and receives an upfront payment of not less than $10,000,000 in connection therewith, and (b) ending on the earlier of September 19, 2015 and the occurrence of an event of default under the Term Loans. After repayment of all outstanding amounts due under two loans from TD Bank, N.A. in the amount of approximately $3,100,000, the proceeds from Term Loan A and Term Loan B may be used to satisfy the Company’s future working capital needs, including the development of its cell therapy product candidates.

The Company will make interest only payments on the outstanding amount of Term Loans on a monthly basis until October 1, 2015 at a rate of 8.5% per annum; provided however, such interest-only period may be extended to April 1, 2016, in the event of either (1) the signing of a partnership for (x) traumatic brain injury indication for the NeoStem, Inc.’s AMR-001 asset or for its “Very Small Embryonic Cell” program; or (y) critical limb ischemia indication for its CD34 program; or (2) the intiation of ‘The Intus Study’, a Phase III study evaluating the Company's product candidate NBS20 (also referred to as DC/TC) in patients with Stage IV or recurrent Stage III metastatic melanoma. Commencing on the date that principal payments commence, the Company shall make consecutive monthly payments of principal and interest based upon a repayment schedule equal to (a) 36 months, if the Term Loans begin amortizing on October 1, 2015, or (b) 30 months, if the Term Loans begin amortizing on April 1, 2016. The Term Loans mature on September 1, 2018. At its option, the Company may prepay all amounts owed under the Loan and Security Agreement (including all accrued and unpaid interest), subject to a prepayment fee that is determined based on the date the loan is prepaid. The Company is also required to pay Lender a final payment fee equal to 8% of the Term Loan A and Term Loan B (if disbursed). The Company paid a facility fee in the amount of $100,000 in connection with Term Loan A. In the event the proceeds of Term Loan B are disbursed, the Company will be required to pay an additional facility fee of $33,333.

Under the Loan and Security Agreement and a related mortgage, the Company granted to Lender a security interest in all of the Company’s real property and personal property now owned or hereafter acquired, excluding intellectual property, and certain other assets and exemptions. The Company also entered into a Mortgage and Absolute Assignment of Leases and Rents (the "Mortgage"). The Company also granted Lender a security interest in the shares of the Company’s subsidiaries. The Loan and Security Agreement restricts the ability of the Company to: (a) convey, lease, sell, transfer or otherwise dispose of any part of its business or property; and (b) incur any additional indebtedness. The Loan and Security Agreement provides for standard indemnification of Lender and contains representations, warranties and certain covenants of the Company. Upon the occurrence of an event of default by the Company under the Loan and Security Agreement, Lender will have customary acceleration, collection and foreclosure remedies.

NEW YORK, Sept. 11, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), a leader in the emerging cellular therapy industry, announced today that the Company has entered into an exclusive license agreement with The Rockefeller University for patented technologies that further expand the Company's intellectual property portfolio associated with its Targeted Cancer Immunotherapy Program.

The discovery of dendritic cells in 1973, resulting in a 2011 Nobel Prize in Physiology or Medicine, bridged the two principal aspects of immunity (innate and adaptive) first defined by Nobel Prize recipients in Physiology or Medicine in 1908. It was subsequently proved that dendritic cells, part of the innate immune system, orchestrate the immune response to specific antigens by absorbing antigens and, when activated, present the specific antigens to B and T cells that result in antigen specific adaptive immunity. The Rockefeller University patents licensed by NeoStem are titled:"Methods for use of Apoptotic Cells to Deliver Antigen to Dendritic Cells for Induction or Tolerization of T Cells," (inventors: Matthew Albert, Nina Bhardwaj, Ralph M. Steinman, Kayo Inaba and Robert Darnell). Studies showed that dendritic cells can be removed from the body in their inactive form, loaded with antigens and then re-infused and activated leading to an antigen specific immune response, including immune responses directed against cancer antigens.

"By licensing these patents that relate to NeoStem's DC/TC (dendritic cell/tumor cell) technology, which technology was acquired by us through the California Stem Cell, Inc. acquisition in May 2014, NeoStem continues to look proactively for opportunities to expand and defend its technology platform as we simultaneously plan to initiate our Phase 3 Intus clinical study that will investigate our DC/TC technology in metastatic melanoma this year," commented Dr. Andrew L. Pecora, Chief Visionary Officer of NeoStem.

This additional intellectual property from The Rockefeller University expands the breadth of the Company's already comprehensive Targeted Cancer Immunotherapy Program patent portfolio, which portfolio includes inventions relating to critical aspects of a dendritic cell-based therapy, such as novel antigen-presenting cancer vaccines, stem cell growth media, and methods to produce the high purity cancer initiating (stem) cells that provide the critical antigen array with which the vaccine's dendritic cells are pulsed.

NEW YORK, Sept. 8, 2014 (GLOBE NEWSWIRE) --

Dear NeoStem Shareholders,

We believe that cell therapy will play a large role in changing the natural history of diseases as breakthrough therapies are investigated and developed, ultimately lessening the overall burden of disease on patients and their families as well as the economic burden that these diseases impose upon modern society. In that vein, we are building NeoStem to be a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through our efforts to develop cell based therapeutics that prevent, treat or cure disease. Our cell therapy platforms seek to address the pathology of disease using a person's own cells in order to amplify the body's natural repair mechanisms including enhancing the destruction of cancer initiating cells, repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function.

At NeoStem, our mission is to transform the future of medicine with innovative cell based therapies while providing development and manufacturing services that drive the industry forward. We are committed to showing the world the path to better medicine. Our goal is to reduce a lifetime dependency on pills to a single dose of cells and help society reduce the burden of an unsustainable healthcare system. Our vision is a world where chronic disease is a problem of the past and patients have the freedom to enjoy a healthier span of life. We truly believe that cell therapies will be better medicine.

Our business includes the investigation of novel proprietary cell therapy products, as well as a revenue-generating contract development and manufacturing service business that we leverage in the development efforts for our therapeutics while providing service to other companies in the cell therapy industry. We believe this combination provides us with unique capabilities for cost effective in-house product development and immediate revenue and future cash flow to help underwrite our internal development programs.

A review of the current status of the cell therapy sector reveals NeoStem as a standout enterprise given our multi-dimensional and diversified approach to accelerating our clinical pipeline through acquisition, internal executive hires and pursuit of multiple independent platforms to support our capacity to grow shareholder value. The key drivers of our growth will relate to the generation of late stage clinical data, the diversity of our platforms, and our unique set of industry specific skills.

Second Quarter 2014 Financial Results:

• Total revenue for the three months ended June 30, 2014 was $4.5 million, up 3 percent from $4.4 million for the prior year period.
• Adjusted EPS of -$0.33 vs -$0.41 in prior year.

"NeoStem has had an exciting first half as we make progress towards our goal of delivering transformative cell based therapies. We expect to continue to build on our progress through the rest of 2014 with a number of important programs," said Dr. Robin Smith, Chairman and CEO of NeoStem. These include:

• Anticipated release of Phase 2 data from the PreSERVE AMI trial of NBS10:This randomized, double-blind, placebo-controlled clinical trial is testing NBS10, the Company's second most advanced product candidate and lead candidate in its ischemic repair program, an autologous adult stem cell product, to treat patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI).
• If successful, NBS10 would address a significant unmet medical need as the indication currently has no effective treatment. For those suffering a STEMI this treatment has the potential to improve longevity and quality of life and positions NeoStem to capture a meaningful share of the worldwide market. The Company is evaluating other clinical indications that might benefit from this ischemic repair platform technology, including traumatic brain injury, chronic heart failure and critical limb ischemia.
• Initiation of the Intus Phase 3 clinical trial of NBS20 for melanoma: NeoStem's lead product candidate, NBS20, also referred to as DC/TC (dendritic cell/tumor cell), which targets malignant melanoma initiating cells, is designed to treat Stage IV or recurrent Stage III metastatic melanoma and is both the Company's lead product candidate n its targeted immunotherapy program for cancer as well as its overall lead product candidate in development. The immunotherapy has been granted fast track and orphan designation by the U.S. Food and Drug Administration (FDA) and the protocol is the subject of a Special Protocol Assessment (SPA). Under the SPA, the FDA is in agreement with the design, clinical endpoints, and planned clinical analyses of the Phase 3 trial that would serve as the basis for a Biologics License Application (BLA) that would be filed at the time NeoStem would request marketing approval. The protocol calls for enrolling 250 evaluable patients and is expected to be initiated in 2014.
• Initiation of clinical trials in Immune Modulation Program using T regulatory cells: NeoStem's immune modulation program is based on the premise that many autoimmune diseases are caused by an imbalance in the immune system between the T-effector cells and the T-regulatory cells. By expanding and re-infusing a patient's own T-regulatory cells, we believe the immune system can be brought into balance and the autoimmune attack can be suppressed. Presentation by UCSF on June 15th at the American Diabetes Association annual meeting of the results of a Phase 1 study of autologous T regulatory cells in adult patients with type 1 diabetes mellitus (T1DM) indicated safety and tolerability following administration, and complements recently published 12-month follow up data showing feasibility and preliminary evidence of efficacy in children with T1DM. Taken together, the results provide preliminary data that support developing a novel therapy for the treatment of T1DM with the goal of inducing immune tolerance and preserving pancreatic beta cell function.
• Subject to review and approval of the protocols by the appropriate regulatory authorities, NeoStem plans to initiate a Phase 2 study of NBS03D for the treatment of type 1 diabetes and a Phase 1 study of NBS03A in support of a steroid resistant asthma development program in 2014. The therapeutic opportunity is to down-regulate the production of inflammatory cytokines by the T cells instead of treating the cytokines after they have been produced, which is the approach of many current therapies.

Dr. Smith continued, "A review of the current status of the cell therapy sector reveals NeoStem as a standout enterprise given its multi-dimensional and diversified approach to accelerating its clinical pipeline by acquisition, internal executive hires and pursuing multiple independent platforms so as not to limit our capacity to grow shareholder value. The key drivers of our near and longer term growth will relate to the generation of clinical data and the diversity of our platforms."

NEW YORK, June 12, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, is issuing this press release to clarify for shareholders that NeoStem is not engaged in a new financing. The registration statement filed today is merely a renewal of an outstanding registration statement covering the issuance of shares underlying warrants that were issued in 2011 and 2012 and remain outstanding. The underlying shares were previously registered, but the registration statement is expiring under SEC rules and needs to be refreshed.

No new securities are being offered by NeoStem.

30,000,000
plus 150,000 Commitment Shares

Neostem, Inc.

Common Stock

Pursuant to this prospectus supplement and the accompanying prospectus, we are offering up to $30,000,000 plus 150,000 Commitment Shares of our common stock, par value $0.001 per share (“Common Stock”), to Aspire Capital Fund, LLC under a Common Stock Purchase Agreement entered into on March 10, 2014.

The shares offered include (i)150,000 shares of Common Stock to be issued to Aspire Capital Fund, LLC in consideration for entering into the Common Stock Purchase Agreement and (ii) additional shares of Common Stock with an aggregate offering price of up to $30,000,000 which may be sold from time to time to Aspire Capital Fund, LLC until June 2, 2016. The purchase price for the additional shares of stock will be based upon one of two formulas set forth in the Common Stock Purchase Agreement depending on the type of purchase notice we submit to Aspire Capital from time to time.

First  Quarter 2014 Results

• Revenues for the three months ended March 31, 2014 were $4.1 million compared to $2.5 million for the same period in 2013, representing a 61% increase.
• Net loss for the first quarter was $9.3 million, or $-0.33 excluding non-cash charges, compared to $6.2 million when excluding non-cash charges, or $-0.37 in prior year.

"We are pleased to see positive revenue growth in this quarter over first quarter 2013 and to report that, as of March 31, 2014, we had an ending cash balance of over $41 million," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "Coupled with our best in class manufacturing capability, the stage is set for us to realize meaningful clinical development and manufacturing efficiencies, further positioning NeoStem to lead the cell therapy industry and achieve our goal of delivering transformative cell based therapies to the market to help patients suffering from life-threatening medical conditions."

California Stem Cell Acquisition

Melapuldencel-T, developed by CSC and now NeoStem's most advanced product candidate and foundation for its Targeted Immunotherapy Program in oncology, is a late stage novel proprietary cancer cell therapy. NeoStem plans to initiate, before the end of 2014, a pivotal Phase 3 trial of Melapuldencel-T, an autologous, melanoma initiating (stem) cell immune based therapy intended to eliminate the tumor cells capable of causing disease recurrence. Melapuldencel-T has been approved to enter this trial with a Special Protocol Assessment ("SPA") from the Food and Drug Administration ("FDA") and has received Fast Track designation for metastatic melanoma, as well as Orphan Drug designation. There are approximately 120,000 new cases of melanoma every year in the U.S.

Pursuant to the terms of the CSC merger agreement, on May 8th NeoStem issued 5.33 million shares of NeoStem common stock, restricted and subject to certain holding periods, in exchange for all of CSC's equity interests. CSC shareholders will be eligible for milestone and royalty payments of up to $90 million, which may be payable in cash or shares of NeoStem common stock at NeoStem's discretion. The shares of NeoStem's common stock issued to equity holders of CSC are not registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements and are subject to selling restrictions.

Item 2.01. Completion of Acquisition or Disposition of Assets.
Item 3.02. Unregistered Sales of Equity Securities.

Closing of California Stem Cell Acquisition

On May 8, 2014 (the “Closing”), NeoStem, Inc., a Delaware corporation (“NeoStem” or the “Company”) closed its acquisition (the “CSC Acquisition”) of California Stem Cell, Inc., a Delaware corporation (“CSC”), pursuant to the terms of the previously-announced Agreement and Plan of Merger, dated as of April 11, 2014 (the “Merger Agreement”), by and among NeoStem, CSC, NBS Acquisition Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of NeoStem (“Subco”), NBS Acquisition Sub II, LLC, a Delaware limited liability company and a wholly-owned subsidiary of NeoStem (“Subco II”), and Jason Livingston, solely in his capacity as CSC stockholder representative (together with his permitted successors, the “CSC Representative”). At Closing, Fortis Advisors LLC succeeded to the duties of the CSC Representative pursuant to the Merger Agreement.

Pursuant to the Merger Agreement, on the Closing Date, (1) Subco was merged with and into CSC (the “First Merger”) and (2) CSC was then merged with and into Subco II (the “Second Merger”, and collectively with the First Merger, the “Mergers”), with Subco II surviving the Mergers as a wholly-owned subsidiary of NeoStem. At Closing, Subco II changed its legal name to NeoStem Oncology, LLC. In this Current Report on Form 8-K, we sometimes use the terms “CSC”, “NeoStem Oncology, LLC” or “Surviving Company” to refer to the wholly-owned subsidiary of NeoStem which is the survivor of the Mergers.

CSC (which after the Mergers is known as NeoStem Oncology, LLC) is a biopharmaceutical company with deep expertise in stem cell biology that is engaged in the development of therapies using a patient’s own, i.e., autologous, cells. To date, CSC’s development efforts have been directed at immunotherapies for cancer, regenerative medicine for motor neuron replacement and dermatology. CSC’s most advanced program is an immunotherapy, Melapuldencel-T, which uses patients’ own tumor cells to maximize the ability of their immune system to identify and eliminate the cancer initiating (stem) cells that are capable of reconstituting or developing new tumors (i.e., “replicating cells”). The focus of that program is the treatment of metastatic melanoma. As a result of encouraging Phase 2 data, CSC expects to initiate a Phase 3 clinical trial later in 2014, for which it has received Special Protocol Assessment (“SPA”) and Fast Track designation, as well as Orphan Drug designation. CSC maintains corporate offices and research facilities in Irvine, California. Further information with respect to CSC’s business and the risk factors associated therewith appears below under the respective captions “Business of CSC” and “Risk Factors.”

Capitalized terms used but not otherwise defined in this Current Report on Form 8-K shall have the respective meanings ascribed to such terms in the Merger Agreement.

Aggregate Merger Consideration

Pursuant to the terms of the Merger Agreement, all shares of CSC common stock (“CSC Common Stock”) and CSC preferred stock (“CSC Preferred Stock”, and collectively with the CSC Common Stock, the “CSC Capital Stock”) outstanding immediately prior to the Closing, were canceled and converted into the right to receive, in the aggregate (and giving effect to the liquidation preferences accorded to the CSC Preferred Stock):

 
(1)  An aggregate of 5,329,593 shares of NeoStem common stock (subject to payment of nominal cash in lieu of fractional shares) (the “Closing Merger Consideration”).

(2) If payable after the Closing, certain milestone payments in an amount of up to $90 million in the aggregate, payable in shares of NeoStem common stock or cash, in NeoStem’s sole discretion, in the event of the successful completion of certain milestone events in connection with the CSC business acquired by NeoStem (the “Milestone Payments”, and together with the Closing Merger Consideration, the “Merger Consideration”). The Milestone Payments that may become payable after Closing (including the relevant payment procedures) are described in greater particularity in NeoStem’s Current Report on Form 8-K filed on April 14, 2014 under the caption “Aggregate Merger Consideration - Milestone Payments,” which discussion is incorporated by reference herein.

The merger consideration as provided in the Merger Agreement was negotiated at arms’ length between the parties.

Payment of Closing Merger Consideration

In accordance with the Merger Agreement, at the Closing and following payment by NeoStem of CSC's current transaction expenses in an aggregate amount of $1.8 million, NeoStem issued (or shall issue, following compliance with letter of transmittal procedures, as applicable) the shares of NeoStem common stock constituting the Closing Merger Consideration, subject to payment of nominal cash in lieu of fractional shares, as follows (and giving effect to the liquidation preferences accorded to the CSC Preferred Stock):

 
(1) 3,744,740 shares of NeoStem restricted common stock shall be distributed to the former holders of CSC Common Stock and CSC Preferred Stock (collectively, the “CSC Securityholders”), following compliance with letter of transmittal procedures.

(2) 1,332,399 shares of NeoStem restricted common stock (the “Escrow Amount”) were deposited with the escrow agent, who is initially NeoStem’s transfer agent (the “Escrow Agent”), to be held on behalf of the former CSC Securityholders for a period of 15 months.

(3) 252,454 shares of NeoStem restricted common stock (the “CSC Expenses Escrow Amount”) were deposited with the Escrow Agent, to be held on behalf of the former CSC Securityholders for a period of 12 months.

Escrow Agreement

In accordance with the Merger Agreement, NeoStem has deposited the shares of NeoStem common stock constituting the Escrow Amount and the CSC Expenses Escrow Amount with the Escrow Agent for eventual distribution to the former CSC Securityholders (subject to adjustment following the Closing in connection with any indemnification claims, all in accordance with the Merger Agreement). Pursuant to the Escrow Agreement entered into at Closing by and among NeoStem, CSC, the CSC Representative and the Escrow Agent (the “Escrow Agreement”), the escrow of the Escrow Amount and the CSC Expenses Escrow Amount will continue from Closing until the 15-month anniversary of the Closing and the 12-month anniversary of the Closing, respectively. The amount of shares ultimately released from escrow to the former CSC Securityholders may (i) in the case of the Escrow Amount, be less than the full Escrow Amount to the extent any portion thereof is required to be applied to cover indemnification claims and (ii) in the case of the CSC Expenses Escrow Amount, be less than the full CSC Expenses Escrow Amount in the event that 50% of the amount of certain offsetting funds received by CSC in the 12 months after Closing from the license of CSC technology, pursuant to grant programs on account of CSC technology or pursuant to donations related to any of CSC’s clinical programs (“CSC Expenses Offset Payments”) does not equal at least $1.8 million, in each case in accordance with the terms of the Merger Agreement. The terms of the escrow arrangements covering the escrowed portions of the Closing Merger Consideration are described in greater particularity in NeoStem’s Current Report on Form 8-K filed on April 14, 2014 under the caption “Aggregate Merger Consideration - Escrow Agreement,” which discussion is incorporated herein by reference. The foregoing description of the Escrow Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Escrow Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.

Private Placement; Transfer Restrictions

The offer and sale of the shares of NeoStem common stock to be issued pursuant to the Merger Agreement (including the Closing Merger Consideration and any Milestone Payments made in shares) have been made in a private placement in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), for transactions by an issuer not involving a public offering, and/or Regulation D under the Securities Act. All certificates evidencing shares of NeoStem common stock issuable in connection with the transactions will bear a standard restrictive legend under the Securities Act. Any portions of the Closing Merger Consideration not deposited into escrow at Closing (the “Closing Share Consideration”) may not be transferred, directly or indirectly, without the consent of NeoStem until the first anniversary of the Closing; provided that following the six-month anniversary of the Closing, this restriction shall lapse with respect to 1,872,370 of the Closing Share Consideration.

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the Merger Agreement, which is filed as Exhibit 2.1 hereto, and is incorporated herein by reference. The provisions of the Merger Agreement, including the representations and warranties contained therein, are not for the benefit of any party other than the parties to such agreement and are not intended as a document for investors and the public to obtain factual information about the current state of affairs of the parties to that document. Rather, investors and the public should look to other disclosures contained in NeoStem’s filings with the SEC.

Item 1.01. Entry into a Material Definitive Agreement.

California Stem Cell, Inc. Merger Agreement

On April 11, 2014, NeoStem, Inc., a Delaware corporation (“NeoStem” or the “Company”) and California Stem Cell, Inc., a Delaware corporation (“CSC”), entered into an Agreement and Plan of Merger (as such agreement may be amended from time to time, the “CSC Merger Agreement”), among NeoStem, CSC, NBS Acquisition Sub I, Inc., a Delaware corporation (“Subco”), NBS Acquisition Sub II, LLC, a Delaware limited liability company (“Subco II”), and Jason Livingston, solely in his capacity as CSC stockholder representative (together with his permitted successors, the “CSC Representative”).

Pursuant to the terms of the CSC Merger Agreement, Subco (a newly-formed wholly-owned subsidiary of NeoStem) will be merged with and into CSC (the “CSC Merger” or the “CSC Acquisition”), with CSC surviving the CSC Merger as a wholly-owned subsidiary of NeoStem. As soon as practicable after the effective time (the “Effective Time”) of the CSC Merger, CSC will be merged with and into Subco II, another newly-formed wholly-owned subsidiary of NeoStem (the “Subco II Merger”, and collectively with the CSC Merger, the “Mergers”). Subco II, in its capacity as the wholly-owned subsidiary of NeoStem surviving the transactions contemplated by the CSC Merger Agreement, is sometimes referred to herein as the “Surviving Company”.

CSC is focused on the application of high-purity human cells in developing therapies, including its Melapuldencel-T platform cancer technology which has been approved to enter Phase 3 clinical trials, with Special Protocol Assessment (SPA) and Fast Track designation, in metastatic melanoma. Since its founding in 2005, CSC has developed proprietary methods for the scalable production of high-purity human stem cells and their derivatives. The ability to generate these cell types at high-purity in large quantities puts CSC’s therapeutic platforms in a position to address critical unmet needs. CSC, a privately-held Delaware corporation, maintains corporate headquarters and research facilities in Irvine, California.

NEW YORK, March 13, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company") today announced 2013 year end results and provided an update on its business.

NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation.

"NeoStem is positioned for significant transformation in our product pipeline in 2014," commented Dr. Robin Smith, NeoStem's Chairman and CEO. "In addition to announcing clinical results for product candidates in both our CD34 Cell Program for ischemic repair and T Regulatory (Treg) Cell Program for immune modulation, we plan to advance these programs in studies that include type 1 diabetes, chronic heart failure and steroid resistant asthma. Additionally, our wholly owned contract manufacturing business, PCT, will continue to prepare for successful commercial-scale manufacturing through its newly formed Engineering & Innovation Center designed to support the manufacturing of high quality products with a reasonable cost of goods."

2013 Year-End Financial Highlights from Continuing Operations

• Revenues for the year were $14.7 million compared to $14.3 million in 2012. PCT's clinical services revenues, representing the largest component of revenues, increased 14%. These revenues were impacted by the deferral of revenue on certain process development contracts, in accordance with our revenue recognition policy. The revenue increase was also partially offset by lower clinical service reimbursable revenue due changes in certain customer contractual terms. Overall, there were approximately 50% more active clients compared to 2012.
• Year-end cash balance was $46.1 million.
• Operating expenses were $38.5 million compared to $32.8 million in 2012. Research and development expenses increased $6.5 million in support of our Phase 2 PreSERVE AMI trial and the advancement of our Treg Program. Selling, general and administrative expenses decreased $0.7 million.
• Net loss from continuing operations was $39.5 million compared to $36.1 million in 2012.
• Net loss excluding non-cash charges was $28.7 million (see reconciliation in the Appendix below).

2014 Outlook

In 2014, NeoStem's management looks forward to significant additional achievements. The Company's milestones and goals for the year include:

NEW YORK, March 6, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, announced today that it has entered into a sponsored research collaboration with Massachusetts Eye and Ear/Schepens Eye Research Institute, an affiliate of Harvard Medical School.

In this collaboration, NeoStem will sponsor research in the laboratory of principal investigator Michael Young, Ph.D., Director of the Ocular Regenerative Medicine Institute at Mass. Eye and Ear in Boston. The objective of the research is to investigate the role of very small embryonic-like stem cells ("VSELs�"), as well as CD34+ cells, in a study that will compare the efficacy of these two cell types for retinal repair. 

"We are enthusiastic about continuing to work with NeoStem to explore the regenerative potential of their human VSEL� Technology," said Dr. Michael Young. "Our work will use animal models to determine whether highly enriched human VSELs�, when injected in the vitreal or subretinal space, can migrate and integrate into areas of damage and have the ability to differentiate and express markers of retinal stem cells, neuronal cells, and photoreceptors."

"We are excited to build upon the relationship we have established with Mass. Eye and Ear/Schepens and work with Dr. Michael Young to advance research to determine the potential of VSELs� to treat ocular diseases such as macular degeneration, retinitis pigmentosa, and other retinal degenerative diseases that have no effective treatment options today," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

NEW YORK, NY--(Marketwired - Feb 19, 2014) - NeoStem, Inc. (NASDAQ: NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, announced today that Dr. Robin L. Smith, Chairman and CEO, was interviewed live on Clear Channel's "The Traders Network" hosted by Michael Yorba. This was Dr. Smith's second appearance on The Traders Network. In a two-part interview, Dr. Smith explained the Company's 2014 goals, 2013 achievements, and the increased visibility the Company is achieving in the cell therapy industry.

When asked why investors are interested in NeoStem, Dr. Smith explained how NeoStem has addressed three key risks that investors often assess before investing in a stem cell company; financing, patient enrollment and manufacturing capabilities. NeoStem has addressed these risks by, first, raising over $40 million this past October in its latest round of fundraising. Second, completing enrollment in its Phase 2 clinical trial testing AMR-001, its lead product candidate for cardiovascular disease, demonstrating management's skill in advancing product candidates through the clinical trial regime. And lastly, as the Company has internal manufacturing capabilities through its wholly owned subsidiary, Progenitor Cell Therapy (PCT), there are lower risks and uncertainties associated with manufacturing its cell therapy candidates.

Mr. Yorba and Dr. Smith discussed NeoStem's pipeline of proprietary cell therapy products, which continues to develop, most notably, NeoStem's completion of enrollment in its PreSERVE AMI Phase 2 clinical trial in December 2013, investigating the Company's most advanced product candidate, AMR-001, in preserving heart function after a severe heart attack. Data read out is expected in Q3 2014, and the Company is also exploring AMR-001 for chronic heart failure and traumatic brain injury. NeoStem also continues to advance its T regulatory cell program with the goal of developing treatments for immune modulated diseases such as type 1 diabetes, and inflammatory conditions such as steroid resistant asthma. Finally, NeoStem continues to develop its very small embryonic-like stem cell (VSEL� Technology) platform in preclinical models with the goal of advancing into early clinical studies to explore the therapeutic potential of VSEL� Technology in indications such as bone repair, healing complex skin and soft tissue wounds, and age-related macular degeneration.

In 2013, for the second year in a row, NeoStem was named the number one fastest growing company and number eleven nationally on Deloitte's Technology Fast 500�, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. Deloitte looks at revenue and growth over a five year growth period as a benchmark. When Mr. Yorba asked Dr. Smith about winning this award, she noted that the Company was really proud to have won this award and to be in the company of such highly esteemed peer companies that were also in the running for the award.

Mr. Yorba and Dr. Smith also discussed NeoStem's unique model of growth. Instead of simply building the Company organically, NeoStem has grown through a series of acquisitions, and as such has become one of the fastest growing companies in its sector. NeoStem has completed five M&A transactions, one divestiture, and raised over 180 million dollars, enabling it to bring in key assets. As Dr. Smith explained, growing the Company in this manner has allowed NeoStem to acquire great talent, and the assets to potentially lead the industry. Speaking of NeoStem's revenue-generating operations through PCT, Dr. Smith said, "I think having the manufacturing is a real edge for us because we can generate revenues from the industry, we can lower the cost of goods, we can focus on things that the industry needs as a whole, and not only does it benefit our clients, but it benefits our internal development. We've created a very unique model that seems to be exciting to Wall Street and investors."

NEW YORK, Jan. 6, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced the expansion of intellectual property protection surrounding the Company's lead product candidate, AMR-001, a chemotactic stem cell product enriched for CD34+ cells that treats injury from vascular insufficiency.

The U.S. Patent and Trademark Office has issued a notice of allowance for what is the sixth granted or allowed U.S. patent for AMR-001. Additionally, the European Patent Office has notified the Company of its intention to grant two patents for AMR-001. These represent NeoStem's first European patent allowances for AMR-001 and bring AMR-001's total worldwide patent coverage to 16 granted and allowed patents.

"With patient enrollment for the Phase 2 PreSERVE AMI trial for AMR-001 complete and data expected in Q3 2014, we hope to proceed to a Phase 3 trial for acute myocardial infarction ("AMI") and are planning to enter into other indications, such as congestive heart failure and traumatic brain injury. The continued expansion of our intellectual property portfolio both domestically and internationally expands the commercial possibilities for AMR-001, should it receive regulatory approval," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

"Since the inception of the AMR-001 program, NeoStem has been granted or allowed patents in many geographies beyond the U.S., including Japan, Canada, Russia, Malaysia, the Philippines, and now the European Union," said Dr. Andrew L. Pecora, Chief Visionary Officer of NeoStem. "The addition of protection in Europe creates the potential to access a market where heart attack and cardiovascular disease are significant threats to public health."

If approved by the U.S. Food and Drug Administration and other worldwide regulatory agencies, AMR-001 could address significant unmet medical needs around the world in the treatment of cardiovascular disease. It is estimated that each year cardiovascular disease causes over 1.9 million deaths in the European Union and costs its economy almost $270 billion.  It has further been estimated that in Europe,  6.5 million patients suffer from chronic heart failure and this number is rising due to the ageing of the population. A recent study published in The European Heart Journal (2010) found that  the annual incidence of hospital admission for any AMI varied between 90�312 per 100,000 per year, with the incidence of ST segment elevation myocardial infarction ("STEMI") alone ranging from 44 to 142 per 100,000.

NeoStem recently announced completion of enrollment in its Phase 2 PreSERVE AMI clinical trial, a randomized, double-blind placebo-controlled study testing AMR-001 for the treatment of patients with left ventricular dysfunction following acute STEMI.

Third Quarter 2013 Financial Results

• Revenues from continuing operations for the three and nine months ended September 30, 2013 were $3.7 million and $10.6 million, respectively, compared to $4.4 million and $11.6 million for the same periods in 2012.

Net loss for the three months ended September 30, 2013 was approximately $9.3 million compared to $8.4 million

Robin L. Smith, MD, MBA, Chairman and Chief Executive Officer of NeoStem, commented on the results, "The quarter was marked by excellent progress across several operational and clinical areas. Our pipeline of proprietary cell therapy products continues to develop and we are on track to complete enrollment of our PreSERVE Phase 2 clinical trial with AMR-001 this year. We have expanded our senior management team with several key hires, strengthened our intellectual property portfolio and signed academic collaborations with the University of California, San Francisco (UCSF) and leading researchers relating to our human Regulatory T cells (Treg) platform."

Dr. Smith added, "With the recent, highly successful public equity offering, NeoStem now has cash reserves in excess of $50 million to enable us to advance multiple pipeline projects, grow the contract development and manufacturing business of our wholly-owned subsidiary PCT and position the Company for strategic and business development partnerships. In addition, PCT has reported 50% more Clinical Service active clients, compared to the same period last year. Through Clinical Services, PCT offers its clients and NeoStem process development and clinical manufacturing capabilities on both the East and West Coasts of the U.S., and we expect to complete the expansion of both facilities by the first quarter of 2014."

NEW YORK, Oct. 8, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced the full exercise of the over-allotment option granted to the underwriters to purchase an additional 750,000 shares of its common stock, at a price to the public of $7.00 per share, in connection with the Company's recently announced underwritten public offering of 5,000,000 shares of common stock, bringing total gross proceeds from the offering to $40,250,000, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

NEW YORK, Oct. 3, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced the pricing of an underwritten public offering of 5,000,000 shares of common stock at a public offering price of $7.00 per share. The Company expects to receive $35,000,000 in gross proceeds, before deducting underwriting discounts and commissions and offering expenses payable by the Company. The Company has granted the underwriters a 45-day option to purchase up to 750,000 additional shares of common stock. The Company intends to use the net proceeds from this offering for working capital, including research and development of cell therapeutic product candidates, including AMR-001, expansion of business units, strategic transactions and other general corporate purposes.

The financing is expected to close on or about October 9, 2013, subject to the satisfaction of customary closing conditions.

NEW YORK, Sept. 25, 2013 (GLOBE NEWSWIRE) --

Dear NeoStem Shareholders,

NeoStem (Nasdaq:NBS), a leader in the emerging cellular therapy market, continues to position itself for success through scientific discovery, a diversified product development pipeline that addresses cardiovascular and autoimmune diseases as well as regenerative medicine, an expanding contract development and manufacturing business that serves as its revenue generating arm, and a professional and experienced management team.

We are proud to be at the forefront of a paradigm shift in medicine toward cell therapy � a shift away from treating disease with drugs and toward treating disease with our own cells; a shift away from treating symptoms and toward cures for illnesses that cause the most suffering; a shift away from chemical drug development and toward looking inside ourselves to understand and then amplify our bodies' natural repair mechanism. We firmly believe that the future of medicine emanates from within each of us and NeoStem is dedicated to unlocking the potential of cellular therapy for humankind.

NeoStem prides itself on not being "just another biotech company." In the ever-changing global economy, ingenuity is rewarded. We are building the Company based on the foundation and sector expertise provided by our contract development and manufacturing subsidiary, Progenitor Cell Therapy ("PCT"). As a leader in the cell therapy industry in-process development innovation and cost effective scale-up, PCT supports NeoStem's internal development of its therapeutic programs. Our investments in our therapeutic pipeline, which we have approached with scientific discipline and business and market analysis, include significant opportunities which are protected by an expanding intellectual property portfolio, positioning the Company for dynamic partner collaborations.

As more cellular therapies enter clinical trials and therapies start to become commercially available, scores of scientists, doctors and patients are awakening to a simple reality � cell therapies hold the potential to vanquish a plethora of diseases and dangerous medical conditions. NeoStem is dedicated to its leadership role in cellular therapy and we look forward to an amazing future built on the accomplishments of today.

We have been extremely busy and productive at NeoStem as we continue to implement our Company's strategic growth and development plans, all the while never losing sight of our responsibility to the health and wellness of the public. Our pipeline of proprietary cell therapy products continues to develop and, most notably, we are on track to complete enrollment of our PreSERVE Phase 2 clinical trial this year, investigating the Company's most advanced product candidate, AMR-001, in preserving heart function after a severe heart attack, with data read out 6-8 months after the last patient is infused. PCT continues to strengthen its presence in the contract development and manufacturing arena. And lastly, our Company has undergone a positive corporate change by moving our stock listing to NASDAQ intended to make us more competitive in the marketplace and enhance exposure to institutional shareholders, while at the same time providing investors with the best prices, the fastest execution and lowest cost per trade.

Finally, our search for the brightest talent to make our Company the "best in class" has brought us experienced industry executives that we believe will assist in maximizing shareholder value. We have recently added four new key members to our management team � each a seasoned executive in the field � raising the Company's profile in the industry, increasing our core knowledge and skill base, and increasing our competitiveness amongst our peers. The team members include Dr. Douglas Losordo, Chief Medical Officer; Robert Dickey IV, Chief Financial Officer; Stephen W. Potter, Executive Vice President; and Robert Shaw, Vice President of Commercial Sales, PCT.

I'd like to share details on some of our recent highlights and developments.

NEW YORK, Sept. 17, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the fast growing cell therapy market, today announced that, on September 13, 2013, the Data Safety Monitoring Board ("DSMB") recommended continuing the PreSERVE AMI Phase 2 clinical trial following a third interim data and safety review. The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to treat 160 patients. AMR-001 is being evaluated for the preservation of heart function after a severe heart attack.

"We are grateful to the DSMB for their oversight of the study and pleased with the recommendation to continue enrollment," said Douglas W. Losordo, MD, FACC, FAHA, Chief Medical Officer of NeoStem. "Despite advances in therapy for myocardial infarction (MI), post-MI left ventricular dysfunction is still a harbinger of an unfavorable long-term prognosis. AMR-001 has shown promise as a means of preserving heart muscle function after a heart attack and we are pleased to continue to work with our investigators across the U.S. to complete enrollment."

Jonathan Sackner-Bernstein, MD, FACC, Vice President of Clinical Development and Regulatory Affairs of NeoStem, said, "The recommendation to continue with the trial is consistent with a wide range of publications that support the utility of autologous bone marrow derived CD34+ stem cells for treatment of this high risk population. The results from this double-blind, sham/placebo controlled study will define the path forward for this promising therapy."

"We are very excited and encouraged by the enrollment progress of the PreSERVE Phase 2 clinical trial," said Dr. Robin L. Smith, Chairman and CEO. "We are on track to complete patient enrollment for this trial in 2013 with data read out 6-8 months after the last patient is infused."

NEW YORK, Sept. 16, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced the licensing of three families of patents from the University of California, San Francisco ("UCSF"). NeoStem's worldwide exclusive license to these patents provides incremental protection for the Company's human Regulatory T cell ("Treg") platform, and complements the recently announced collaboration with UCSF and the laboratories of Drs. Jeffrey Bluestone and Qizhi Tang, to develop Tregs for the treatment of type 1 diabetes, steroid resistant asthma, and organ transplant rejection.

The three patent families cover methods to isolate, expand and use Tregs with therapeutic potential for autoimmune disorders, including U.S. patent 7,722,862, which claims a cellular immunotherapy for the treatment of type 1 diabetes.

"In the U.S., type 1 diabetes affects 1.3 million people and has an economic cost of over $14 billion, numbers which are significantly higher worldwide," said Dr. Douglas W. Losordo, Chief Medical Officer of NeoStem. "These patents bolster our existing portfolio in the Treg arena and enhance our ability to combat autoimmune diseases such as type 1 diabetes using Treg therapy."

NeoStem's patent estate for its Treg program now includes exclusive rights to 22 issued patents in U.S. and major international commercial geographies and covers isolation, activation, expansion and methods of treating or preventing certain conditions and/or diseases using Tregs.

Dr. Andrew L. Pecora, Chief Visionary Officer of NeoStem, added , "We are excited about this recent expansion of our intellectual property and about the effect that our collaboration with Drs. Bluestone and Tang, industry leaders in Treg research, and UCSF will have on our Treg program."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, said, "This collaboration advances that program towards a Phase 2 trial to evaluate the efficacy of autologous Tregs in type 1 diabetes, effectively accelerating the Company's pipeline more quickly than had it developed a program for this clinical indication independently."

NEW YORK, Sept. 13, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy industry, today announced that it has been awarded funds for the second year of a two year grant totaling $1,221,854 for "Repair of Bone Defects with Human Autologous Pluripotent Very Small Embryonic-Like Stem Cells (VSEL)," from the National Institute of Dental & Craniofacial Research ("NIDCR"), a division of the National Institutes of Health ("NIH"). This peer reviewed grant is to support a Phase 2 investigation and first approved NIH clinical study of VSELs^TM in humans. Enrollment for this study is expected to begin in 2014.

VSEL� Technology, an autologous therapy derived from a patient's own stem cells, is being developed for use in the regeneration of bone tissue damaged by periodontitis. The Phase 2 trial will be managed by Denis O. Rodgerson, Ph.D., Director of Grants and Academic Liaison for NeoStem, in collaboration with co-investigators Drs. Russell Taichman and Laurie McCauley of the University of Michigan. The award comprised of $706,682 for the first year and $515,172 for the second year of the project, and will cover the cost of the Investigational New Drug ("IND") submission to the FDA for the product candidate.

The required preclinical data, cell manufacturing processes and clinical protocols necessary for submission of an IND to the FDA are in the final stages of preparation. The Company anticipates  IND submission in late 2013 or early 2014.

Dr. Robin L. Smith, Chairman and CEO of NeoStem, commented, "We are very excited about our progress toward the IND submission for what we expect to be the first human clinical study for our VSEL� Technology and for the support of the NIH. We continue to pursue opportunities for non-dilutive financing of our programs, such as our recently awarded phase 1 NIH grant to investigate VSEL� Technology for the treatment of scleroderma."

Dr. Denis O. Rodgerson, Director of Grants and Academic Liaison for NeoStem, added, "We are pleased that we have met our interim milestones and NIH has agreed to award us funding for the second year of these studies on bone regeneration by using VSEL� stem cells."

Periodontitis is a severe form of periodontal disease, which is prevalent in the U.S. and affects up to 90% of the world population. The most severe cases of periodontal disease affect between 5% and 15% of the U.S. population, or between 15 and 47 million Americans. The incidence of new cases of periodontal disease is estimated to be between 1 and 3 million Americans annually, and growing at a 7% rate each year. Studies have shown that periodontal inflammation could have a role in the initiation or progression of coronary heart disease and stroke. Market research experts have estimated that severe periodontal disease represents a market between $1.25 and $1.5 billion annually.

This research is supported by the National Institute of Dental & Craniofacial Research of the National Institutes of Health under Award Number 5R44DE022493-03. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

NEW YORK, Sept. 12, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, today announced that it has received an award under the Small Business Innovative Research Program ("SBIR") of $147,765 for the "Development of Adult Pluripotent Very Small Embryonic Like (VSEL) Stem Cells to Treat Skin Wounds in Scleroderma" from the National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases ("NIH-NIAMS"). This award will fund studies to investigate the potential of very small embryonic-like stem cells ("VSELs�") in treating difficult to heal wounds in an animal model of scleroderma. The grant will support research to be headed by Denis O. Rodgerson, Ph.D., Director of Grants and Academic Liaison of NeoStem, and Dr. Vincent Falanga, M.D., The Barbara A. Gilchrest Professor of Dermatology and Professor of Biochemistry at the Boston University School of Medicine.

The study will employ the tight skin ("Tsk") mouse to test the potential wound healing capabilities of autologous VSELs� in treating difficult to heal skin ulcers in this disease. The Tsk mouse carries a heterogeneous mutation for the fibrillin-1 gene and rapidly exhibits the characteristic tight and thickened skin phenotype of scleroderma patients. Depending on the results of the study, the Company may qualify for up to an additional $1.5 million phase 2 grant for the indication from NIH-NIAMS.

Over 300,000 people in the United States live with scleroderma, an autoimmune, connective tissue disorder which causes fibrosis of the skin and internal organs. Patients with scleroderma have an overproduction of extracellular matrix, and type 1 and 3 collagen. The disease involves vascular breakdown where the blood vessels in the skin degenerate and are replaced by collagen to form fibrotic tissue. The sclerotic tissue can also lead to digital ischemia and ulcers. Because of the vasculopathy, there is diminished blood supply to the lesion making the ulcers difficult to heal, prone to infection and possible progression to gangrene can occur that requires amputation. The ischemic ulcers are frequent, painful, and cause significant morbidity. There is presently no effective treatment of scleroderma or the ischemic ulcers.

"Our collaboration with Dr. Falanga, a recognized expert in the management of chronic wounds and fibrosis, offers NeoStem a solid foundation to advance its investigation into the use of human VSELs� in treating skin wounds and a host of other degenerative diseases and disorders in humans, including scleroderma," said Dr. Denis O. Rodgerson. "This study has the potential to advance treatments that could one day help patients suffering from this and other debilitating autoimmune diseases."

Dr. Vincent Falanga added, "The NIH award will allow us to explore the great potential of these very special stem cells that reside in the bone marrow and that we believe are able to convert to many other cell types and accelerate healing."

"NeoStem is pleased that the NIH has awarded this funding to support NeoStem's continued development of VSEL� Technology as a therapeutic to heal chronic dermal wounds," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We look forward to this study, as well as studies by other academic collaborators, serving as a catalyst for the Company in its investigation of VSEL� Technology therapeutics for multiple clinical indications."

NEW YORK, Aug. 19, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, announced today the appointment of Robert Dickey IV as Chief Financial Officer. Mr. Dickey, an industry veteran as well as former investment banker, is joining the Company effective today. Larry May, the Company's long-time CFO, is assuming the newly-created position of Vice President, Strategic Initiatives, and will assist Mr. Dickey in the transition as well as focus on the Company's various strategic activities.

"I'm excited to join the superb team at NeoStem which now includes the significant recent additions of Dr. Doug Losordo as Chief Medical Officer and Mr. Stephen Potter as Executive Vice President," said Mr. Dickey. "In addition to overseeing the financial function at the Company, I look forward to joining Dr. Smith, the Company's dynamic Chairman and Chief Executive Officer, in working to expand the Company's visibility in the marketplace with a focus on institutional investors and evaluate, structure and assimilate new opportunities in this rapidly growing industry that can further drive shareholder value. I am thrilled to play a part in NeoStem's dedication to strategic growth and its commitment to positively impact the world as cell therapy heralds a new era in medical treatment." 

"Rob has a truly impressive track record in the biotech and pharmaceutical industries and is the ideal candidate to help the Company grow and add shareholder value," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "In his prior roles, Rob has proven himself a key member of leadership teams �driving finance, M&A, strategic deal making and business development. His extensive, on-point experience will provide critical support for the advancement of our development pipeline."

"I'm honored to have served the Company as CFO for many years and excited to continue to serve in my new role," said Mr. May. "NeoStem's strategic activities offer many opportunities and challenges and I hope my years of experience with the Company and the pharmaceutical industry will continue to support their execution. I look forward to collaborating with Robert as he takes on the CFO role to help ensure a smooth transition for the Company."

Mr. Dickey has over 15 years of management experience at life sciences companies, including positions as a CFO, COO and CEO and board member, following a career as an investment banker. He has specific expertise in financing, M&A, partnering/licensing transactions and project management, as well as international experience. Mr. Dickey is joining NeoStem from Hemispherx Biopharma, Inc. where he served as Senior Vice President. Hemispherx is a publicly-traded company involved in immune-modulatory therapies that is developing treatments for chronic fatigue syndrome and influenza. Prior to Hemispherx , Mr. Dickey was Senior Vice President, Chief Financial Officer and Business Unit Manager at StemCyte, Inc., an umbilical cord stem cell therapeutics company. Other management experience includes leadership positions at Protarga, Inc., a company developing cancer therapies, and Locus Pharmaceuticals, a company involved in computational drug design. Previously, he spent 18 years as an investment banker, 14 of those at Lehman Brothers, with a background split between M&A and capital markets transactions across a variety of industries. He earned an M.B.A from The Wharton School, University of Pennsylvania, and an A.B. from Princeton University. 

Second Quarter 2013 Results

• Revenues from continuing operations for the three months ended June 30, 2013 were $4.4 million, compared to $3.4 million for the same period in 2012.
• Reported loss per share of $0.46, compared to a loss per share f $0.53 for the same period in 2012.

Company Updates

Progenitor Cell Therapy ("PCT") -- In Q2 2013, PCT generated $4.4 million, a 73% increase in revenues from Q1 2013.  PCT completed three process development contracts in Q2 2013, triggering higher revenue recognition. PCT also recently signed two new clients, including a large pharmaceutical company that is entering the cell therapy sector, and continues to build its business. PCT has provided services to over 100 clients in its more than 15-year history, and is the only contract manufacturing organization to have worked with a client's product through all of the phases of its clinical trials and ultimately to FDA approval. PCT offers its clients and NeoStem cell processing and development capabilities on both the East and West Coasts of the U.S. and is pursuing plans to expand internationally.

Amorcyte – The Company continued enrollment in its PreSERVE Phase 2 clinical trial with 120 patients infused as of August 8, 2013 and is on track to complete patient enrollment for this trial in 2013 with data read out 6-8 months after the last patient is infused.
     
Athelos – The Company continues to progress with its T-cell program with the goal of developing treatments for immune-mediated diseases, such as autoimmune disorders such as type 1 diabetes ("T1D") and inflammatory conditions such as steroid resistant asthma.  On July 15th, the Company announced that it has executed agreements with the University of California, San Francisco and the laboratories of Jeffrey Bluestone, PhD, and Qizhi Tang, PhD, to collaborate on the development of human Regulatory T cells ("Treg") for the treatment of T1D. This collaboration advances NeoStem's role in the development and commercialization of immunomodulatory cellular therapeutic products for the treatment of intractable diseases involving the immune system. This collaboration also advances NeoStem's Treg program towards a clinical Phase 2 trial to evaluate the efficacy of autologous Tregs in T1D. Under the agreements, NeoStem will manufacture a Treg product consisting of polyclonally expanded Tregs for the planned Phase 2 trial to treat patients newly diagnosed with T1D and will also collaborate with Dr. Bluestone on allo-specific Tregs for organ transplant tolerance in another Phase 2 study.  Additionally, NeoStem plans to sponsor a Phase 1b/2a study on the use of Tregs for the treatment of steroid resistant asthma. The collaboration includes the research effort to develop the next generation of Treg products for therapeutic use.  

NEW YORK, July 23, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), a leader in the emerging cell therapy market, today announced that it has met the listing criteria for the NASDAQ Capital Market and will move its listing from NYSE MKT to the NASDAQ Capital Market effective with the start of trading on August 5, 2013. NeoStem will continue to trade under its existing ticker symbol "NBS". NeoStem's common stock will trade on the NYSE MKT until the market close on August 2, 2013.

"NeoStem's move to NASDAQ aligns with the Company's plans to grow and expand its cellular therapy-based R&D platform and contract manufacturing capabilities, both in the US and internationally," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We believe that NASDAQ will provide our Company with enhanced exposure, while at the same time providing investors with the best prices, the fastest execution and lowest cost per trade. Additionally, we believe that our transfer to the NASDAQ will enhance our public visibility to institutional shareholders. As the world's largest electronic stock market, NASDAQ promotes innovation and attracts leading growth companies from a diverse group of sectors. We are proud to be joining fellow cell therapy industry companies such as Celgene Corporation, Harvard Bioscience Inc., Osiris Therapeutics, Inc., Mesoblast Limited, Stemline Therapeutics, Inc., Verastem, Inc. and Shire PLC on the NASDAQ."

"We are extremely pleased to welcome NeoStem to the NASDAQ Stock Market," said Bruce Aust, Executive Vice President, NASDAQ OMX. "We are confident that a listing with NASDAQ will provide NeoStem with enhanced visibility, greater liquidity and increased exposure to the institutional investment community."

NEW YORK, July 12, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cell therapy market, announced that it is effecting a 1-for-10 reverse stock split of its common stock which will be effective for trading purposes as of the commencement of trading on July 16, 2013. As of that date, each 10 shares of issued and outstanding common stock and equivalents will be converted into 1 share of common stock. In addition, at the market open on July 16, 2013, the common stock will trade under a new CUSIP number 640650404 although the Company's ticker symbol, NBS, will remain unchanged.

The number of outstanding common shares will be reduced from 196,643,748 to approximately 19.7 million. The number of authorized shares and the par value per share will remain unchanged. No fractional shares will be issued in connection with the reverse stock split. Holders of fractional shares will be paid out in cash for the fractional portion with the Company's overall exposure for such payouts consisting of a nominal amount. The number of outstanding options and warrants will be adjusted accordingly, with outstanding options being reduced from 26,366,633 to approximately 2.6 million and outstanding warrants being reduced from 54,297,826 to approximately 5.4 million. NeoStem stockholders will receive instructions from its transfer agent, Continental Stock Transfer and Trust Company, as to procedures for exchanging existing stock certificates for new certificates or book-entry shares and for the receipt of cash proceeds in lieu of fractional shares.

Dr. Robin L. Smith, Chairman and CEO of NeoStem stated, "Over the last few months we have had numerous discussions with investors, advisors and our board about our capital structure. We have also observed that, over the past five years, a number of our peer companies in the regenerative medicine sector have effected reverse stock splits. We believe the resulting increase in share price will demonstrate the true value of NeoStem's common stock and broaden the appeal of our shares to investors, particularly institutional stockholders."

ALLENDALE, N.J. and LOS ANGELES, June 3, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), its subsidiary, Progenitor Cell Therapy LLC ("PCT"), and ImmunoCellular Therapeutics, Ltd. (NYSE MKT:IMUC) ("IMUC"), a clinical-stage biotechnology company that is developing immune-based therapies for the treatment of brain and other cancers, announced today the execution of a Services Agreement under which PCT will provide cGMP ("current good manufacturing practices") manufacturing services to support research and development of IMUC's ICT-121 cell therapy product candidate, a dendritic cell vaccine targeting CD133 cells. PCT currently provides manufacturing services for IMUC's lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma, for its Phase II clinical trial.

"We are pleased with PCT's ability to scale up services, lower our cost of goods and provide high quality manufacturing to support our research and development activities," said Andrew Gengos, Chief Executive Officer of ImmunoCellular. "We look forward to continuing to work in partnership with PCT as we seek to advance our cancer vaccines through the clinical and regulatory process."

"We appreciate the opportunity to work with ImmunoCellular as a manufacturing partner. Our management is focused on growing the business through increased services and product offerings, including automation technologies geared toward improving efficiencies and lowering cost of goods," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. "Whether through growing our client base or expanding or extending services with current clients, we see that the industry is taking notice of the process improvements and cost benefits of working with PCT."

"With its East and West Coast facilities, PCT has unique expertise in manufacturing, regulatory, logistical transport and commercialization for therapeutics development, and we are pleased that our clients have confidence in the quality and cost-effectiveness of our operations," said Robin L. Smith, M.D., MBA, Chairman and CEO of NeoStem. "We foresee meaningful client base growth as therapeutic development companies come to understand the critical importance of involving a skilled manufacturing partner and the cost-effectiveness of that partner possessing the ability to rapidly scale while providing excellent service."

NEW YORK, May 16, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced the geographic expansion of intellectual property protection around its lead product candidate, AMR-001, with the notice of patent grant in Malaysia (MY-147516-A) and notice of recommendation for patent allowance in the Philippines (1-2008-501074). These patents are in the family of U.S. patent number 7,794,705 titled "Compositions and Methods of Vascular Injury Repair" and protect a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction ("AMI").

Additionally, NeoStem has been granted a second South African patent (ZA 2011/04059) titled "Infarct Area Perfusion-Improving Compositions and Methods of Vascular Injury Repair."

"These incremental patents will bring AMR-001's total worldwide patent coverage to nine patents," said Dr. Andrew L. Pecora, Chief Medical Officer of NeoStem. "The Asian and African geographic expansion of Amorcyte's patent protection, which also includes Japan as previously announced, creates the potential to access markets where heart attack and cardiovascular disease are significant threats to public health."

According to reports, cardiovascular disease is a significant problem in the Philippines, South Africa and Malaysia. The populations in each of these countries are 95 million, 51 million, and 29 million respectively.

• Heart disease is the number one killer in both Malaysia and the Philippines, accounting for 1 out of every 5 deaths in the Philippines.
• The prevalence of risk factors for heart disease is significant in Malaysia, with physical inactivity at 60.1%, smoking at 25.5%, and hypertension at 25.7%.
• In South Africa, approximately 130 heart attacks occur every day, or almost 50,000 per year.
• Premature deaths from cardiovascular disease in South Africa are projected to increase by 41% by 2030 in people from 35-64 years old.

NeoStem's AMR-001 is a cell therapy in development for the treatment of cardiovascular disease. The Company is on track to complete enrollment in 2013 of patients in the Phase 2 PreSERVE AMR-001 double-blinded clinical trial to investigate AMR-001's safety and efficacy in preserving heart function after a heart attack in a particular type of post-AMI patient. NeoStem expects to have the first data readout available six to eight months after the last patient is enrolled. If approved by the U.S. Food and Drug Administration ("FDA") and/or other worldwide regulatory agencies, AMR-001 would address a significant unmet medical need in the treatment of AMI and position the Company to capture a meaningful share of the worldwide AMI market. "These notices are testament to the strength of the AMR-001 product candidate and we expect to see further expansion of our intellectual property in the coming years," said Dr. Robin L. Smith, Chairman and CEO of NeoStem.

ALLENDALE, N.J. and WASHINGTON, May 13, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced today that PCT has entered into a Cell Therapy Processing Customer Agreement with MedStar Georgetown University Hospital in Washington, D.C. to provide autologous and allogeneic cellular therapy services for cellular products provided by MedStar Georgetown University Hospital ("MGUH") and deliver resulting cellular therapy products to MGUH for patient care.

In April, Georgetown's Lombardi Comprehensive Cancer Center, part of MedStar Georgetown University Hospital, and the John Theurer Cancer Center, part of Hackensack University Medical Center ("HackensackUMC") in Hackensack, N.J., announced the establishment of an oncology affiliation arrangement between them to enhance patient access to innovative clinical trials, and is a significant step towards developing a clinical, translational and basic science cancer research consortium.

In its agreement with PCT, MedStar Georgetown University Hospital will use the services of PCT for processing and storage of peripheral blood progenitor cells, donor leukocytes, bone marrow and cord blood, as well as requested assaying and storage of cellular therapy product, and retrieval and transportation logistics.

"Akin to our relationship with HackensackUMC, whose engagement of PCT began over thirteen years ago, we look forward to developing a strong association with Georgetown," said Robert A. Preti, Ph.D., President and Chief Scientific Officer of PCT. "Our agreements with HackensackUMC and MedStar Georgetown University Hospital enable us to continue to play a vital part in patient care for cancers and other hematologic disorders, and to continue to provide cell products to our entire client base. Since its founding, PCT has provided cell therapy products for infusion into over 6,000 patients."

Dr. Robin L. Smith, NeoStem's Chairman and Chief Executive Officer, stated that, "NeoStem is committed to supporting and enabling the development of emerging cell therapy products. We, as well as our clients, are developing innovative therapies using the cells of our body to treat chronic diseases such as cancers, autoimmune conditions and cardiovascular disease. We are thrilled to be working with prestigious institutions such as MedStar Georgetown University Hospital and HackensackUMC to support their bone marrow transplant programs. PCT's exceptional client retention rate validates the management's commitment to Quality and Service as we look forward to future growth with our clients outside of the United States."

NEW YORK, May 9, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), a leader in the emerging cellular therapy industry, is issuing this press release to clarify for shareholders that NeoStem is not engaged in a new financing. The registration statement filed today is merely a renewal of an outstanding registration statement covering the issuance of shares underlying warrants (exercisable at per share prices of $1.43 and greater) that were issued 3 years ago and remain outstanding. The underlying shares were previously registered but the registration statement is expiring under SEC rules and needs to be refreshed.

No new securities are being offered by NeoStem.

NEW YORK, May 3, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced the closing of a previously announced underwritten public offering of 23,000,000 shares of its common stock, including the fully exercised over-allotment option by the underwriters covering 3,000,000 shares, offered at a price to the public of $0.50 per share. The gross proceeds to the Company were $11,500,000, before deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Aegis Capital Corp. acted as sole book-running manager of the offering.

NEW YORK, April 29, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced that it intends to offer for sale shares of its common stock in an underwritten public offering. The Company intends to use the net proceeds from this offering for working capital, including research and development of cell therapeutic product candidates, including AMR-001, expansion of business units, strategic transactions and other general corporate purposes. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Aegis Capital Corp is acting as sole book-running manager in the offering.

ALLENDALE, N.J., April 29, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy LLC ("PCT"), announced today the execution of a Services Agreement with Sentien Biotechnologies, Inc. ("Sentien") under which PCT will provide services to support Sentien's development of its cell therapy product, including technology transfer, staff training, and manufacturing.

Sentien is developing an allogeneic cell therapy product consisting of bone marrow derived mesenchymal stem cells seeded onto a medical device for critical care indications. Sentien has engaged PCT for manufacture of the final formulation of its cell therapy product and intends to transfer and implement Sentien's master cell bank, product working cell bank and product manufacturing processes to PCT. These cell banks will be prepared according to Good Manufacturing Practices ("GMP") guidelines and implemented by PCT to create a cell therapy product for Sentien's Investigational New Drug ("IND") submission to the FDA. Upon obtaining an IND, Sentien intends to have PCT manufacture GMP compliant grade materials to support Sentien's Phase I clinical trial. 

 "We are excited to enter into this agreement with Sentien, an innovator for acute organ failure," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. PCT is an internationally recognized contract development and manufacturing organization with facilities in Allendale, New Jersey and Mountain View, California. The company has expertise in GMP manufacture for cell therapies, including dendritic cells, stem cells and T cells. Notably, PCT provided manufacturing for the pivotal studies for Dendreon's Provenge�, the first cell therapy approved for cancer treatment.

Dear NeoStem Shareholders,

NeoStem (NYSE MKT:NBS) is rapidly emerging as a technology and market leading company in the fast developing cell therapy market. Our multifaceted business strategy combines a state-of-the-art contract development and manufacturing organization (CDMO) with a medically important cell therapy product development program enabling immediate and long-term revenue growth opportunities. Our service business and pipeline of proprietary cell therapy products work in concert, giving NeoStem a competitive advantage that is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a dynamic patent and patent pending (IP) portfolio, NeoStem is well positioned to succeed.

We would like to take a moment to update you on the following recent developments and important near term catalysts for the second half of 2012:  Full release.

NEW YORK, June 18, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company") today announced that the Company has entered into a definitive agreement to sell its 51% interest in Suzhou Erye Pharmaceutical Co. Ltd. ("Erye"), a China-based generic pharmaceutical company, for $12,280,000 in cash and the return to the Company of (i) 1,040,000 shares of the Company's Common Stock and (ii) the cancellation of 1,170,000 options and 640,000 Common Stock warrants, which collectively represent 1.3% of the Company's fully diluted issued and outstanding shares. The closing of the transaction is subject to the approval of NeoStem shareholders and certain other conditions. Closing of the transaction is expected to occur by the fourth quarter of 2012.

"We are pleased to have reached this significant milestone in our business," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "This divestiture will enable NeoStem to bolster its cash position in the United States, reduce its legal and financial reporting expenditures, simplify its financials and become a pure play in the rapidly growing cell therapy industry. Consummation of the transaction will also eliminate significant Erye debt from the Company's balance sheet, which was over $37 million as of March 31, 2012."

NeoStem acquired its interest in Erye in October 2009 and was heralded, at that time, for its innovative business move into the emerging Chinese pharmaceutical industry. In 2011, the Chinese government imposed new policies affecting price and volume controls of certain pharmaceutical products, including generic antibiotics, which reduced the division's profitability and positive cash flows. This dampened Erye's operating results and was the catalyst for NeoStem to begin to evaluate opportunities to monetize its interest in Erye.

The divestiture will enable NeoStem to focus full time on its goal to emerge as a leader in the cell therapy market. The Company is enrolling patients in its PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack and expanding its cell therapeutic contract manufacturing business, PCT. NeoStem also plans to continue to develop and to build on its core capabilities in cell therapy to capitalize on the paradigm shift that is occurring in medicine.

Over one million people in the Unites States suffer a heart attack annually. One in five people who survive a heart attack dies within a year. Of those individuals that do live, many of them have worsening heart function over time. NeoStem's Phase 2 therapeutic product candidate, AMR-001, takes stem cells from a person's own body and injects them one time into the heart through the infarct related artery in order to lay down new blood vessels, with the intent of preserving heart function. Management remains focused on the key objective of completing enrollment of the PreSERVE AMR-001 Phase 2 clinical trial in order to have data during the second half of 2013.

NEOSTEM, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

NEOSTEM, INC. AND SUBSIDIARIES
  
Consolidated Statements of Operations

		Years Ended December 31,
		2010				2009				2008
Revenues		$	69,821,294			$	11,565,118			$	83,541
Cost of revenues			49,668,262				9,706,005				31,979
Gross profit			20,153,032				1,859,113				51,562
Research and development			7,684,537				4,327,608				792,182
Selling, general, and administrative			31,346,806				23,400,430				8,492,833
Operating loss			(18,878,311	)			(25,868,925	)			(9,233,453	)
Other income (expense):
Other income (expense), net			513,110				(16,053	)			3,044
Interest expense			(480,903	)			(23,135	)			(11,662	)
			32,207				(39,188	)			(8,618	)
Loss from operations before provision for income taxes and noncontrolling interests			(18,846,104	)			(25,908,113	)			(9,242,071	)
Provision for income taxes			550,912				41,675				—
Net loss			(19,397,016	)			(25,949,788	)			(9,242,071	)
Less – net income attributable to noncontrolling interests			3,908,690				220,865				—
Net loss attributable to NeoStem, Inc.			(23,305,706	)			(26,170,653	)			(9,242,071	)
Preferred dividends			237,963				5,611,989				—
Net loss attributable to NeoStem, Inc. common shareholders		$	(23,543,669	)		$	(31,782,642	)		$	(9,242,071	)
Basic and diluted loss per share		$	(0.46	)		$	(2.44	)		$	(1.53	)
Weighted average common shares outstanding			51,632,417				13,019,518				6,056,886