Posted on April 14th, 2014
by Robin Smith
Since NeoStem was founded in 2006, I have had the immense pleasure as Chairman and CEO of overseeing the growth and transformation of the Company into a truly unique member of the cell therapy industry. One such activity that has helped NeoStem thrive is our understanding of the need to constantly evolve and to recognize value when it is presented to us. We pride ourselves on our innovative culture and our ability to harness the full potential of every asset we have at our disposal.
Today, I am proud to announce NeoStem’s plan to acquire California Stem Cell, Inc. (“CSC”), an Irvine, California based stem cell biotechnology company. As with any acquisition, the Company has carefully evaluated the value proposition of this transaction as it relates to all our constituents. As such, I can say with confidence that we believe the acquisition of CSC, along with its Phase 3 ready asset and impressive technology platform, will prove to be a crucial time of meaningful growth for us when we look back in a year’s time. I am especially excited by our plan to initiate a pivotal Phase 3 trial of CSC’s lead product candidate, a patient specific cancer immunotherapy, to treat patients with late stage metastatic melanoma. The merger is expected to close in May 2014 and is subject to customary closing conditions.
While the Phase 3 ready asset is of course an exciting development for NeoStem, the CSC acquisition represents a wide range of opportunities. CSC’s platform technology is based on their findings that tumors contain specialized cells, referred to as cancer stem cells, which are capable of generating new tumors. As such, the central concept behind CSC’s treatments is derived from the patient’s immunization against cancer stem cells. The end result is a patient specific immunotherapy that targets these cancer stem cells for therapeutic intervention. This platform technology has the potential to address other cancer indications beyond metastatic melanoma, such as hepatocellular carcinoma (liver cancer) and other immune responsive tumor types.
Adding CSC’s advanced immunotherapy technologies to NeoStem’s already diversified development pipeline only adds to our strength in the field. We are proud to be at the forefront of medicine’s shift towards cell therapy and believe the foundational work we are doing today will help us to provide potentially life-changing solutions/treatments for patients in the future. I look forward to what is sure to be a transformative time for the Company and will continue to update you as we move forward.
Robin L. Smith
Chairman and CEO
Forward Looking Statements
This blog contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as well as historical information. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from anticipated results, performance or achievements expressed or implied by such forward-looking statements. When used in this blog, statements that are not statements of current or historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “plan,” “intend,” “may,” “will,” “expect,” “believe,” “could,” “anticipate,” “estimate,” or “continue” or similar expressions or other variations or comparable terminology are intended to identify such forward-looking statements, although some forward-looking statements are expressed differently. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity or our achievements or industry results, to be materially different from any future results, performance levels of activity or our achievements or industry results expressed or implied by such forward-looking statements. Such forward looking statements appear in this blog. Factors that could cause our actual results to differ materially from anticipated results expressed or implied by forward-looking statements include, among others:
• our ability to obtain sufficient capital or strategic business arrangements to fund our operations and expansion plans, including meeting our financial obligations under various licensing and other strategic arrangements, the funding of our clinical trials for product candidates in our development programs for our Targeted Cancer Immunotherapy Program, our Ischemic Repair Program and our Immune Modulation Program, and the commercialization of the relevant technology;
• our ability to build and maintain the management and human resources infrastructure necessary to support the growth of our business;
• our ability to integrate our acquired businesses successfully and grow such acquired businesses as anticipated, including expanding our PCT business internationally;
• whether a large global market is established for our cellular-based products and services and our ability to capture a meaningful share of this market;
• scientific and medical developments beyond our control;
• our ability to obtain and maintain, as applicable, appropriate governmental licenses, accreditations or certifications or comply with healthcare laws and regulations or any other adverse effect or limitations caused by government regulation of our business;
• whether any of our current or future patent applications result in issued patents, the scope of those
patents and our ability to obtain and maintain other rights to technology required or desirable for the conduct of our business; our ability to commercialize products without infringing the claims of third party patents;
• whether any potential strategic or financial benefits of various licensing agreements will be realized;
• the results of our development activities, especially:
• the results of our planned Intus Phase 3 clinical trial of NBS20 being developed to treat metastatic melanoma;
• the results of our PreSERVE Phase 2 clinical trial of NBS10 being developed to treat acute myocardial infarction for which we released initial data on November 17, 2014 and for which all 6 and 12 month data has been collected; however it is subject to ongoing analysis, and currently reported results, although promising, are preliminary and there can be no assurance that further analysis may not reveal negative, or less promising, results;
• our ability to complete our other planned clinical trials (or initiate other trials) in accordance with our estimated timelines due to delays associated with enrolling patients due to the novelty of the treatment, the size of the patient population and the need of patients to meet the inclusion criteria of the trial or otherwise; and
• the other factors discussed in “Risk Factors” in our Form 10-K filed with the Securities and Exchange Commission (“the SEC”) on March 2, 2015, and elsewhere in the Annual Report on Form 10-K.
The factors discussed herein, including those risks described in Item 1A. “Risk Factors” in the Company's Annual Report on Form 10-K filed with the SEC on March 2, 2015 and in the Company's other periodic filings with the Securities and Exchange Commission (the “SEC”) which are available for review at www.sec.gov under “Search for Company Filings” could cause actual results and developments to be materially different from those expressed or implied by such statements. All forward-looking statements attributable to us are expressly qualified in their entirety by these and other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.