Delaware
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86-1032927
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State of Incorporation
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IRS Employer Identification No.
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Large accelerated filer
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o
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Accelerated filer
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þ
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Non-accelerated filer
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o
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Smaller reporting company
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o
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Page
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ITEM 1.
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BUSINESS
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4
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ITEM 1A.
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RISK FACTORS
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32
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ITEM 2.
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PROPERTIE
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68
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ITEM 3.
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LEGAL PROCEEDINGS
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68
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ITEM 4.
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MINE SAFETY DISCLOSURES
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68
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ITEM 5.
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MARKET FOR REGISTRANT'S COMMON STOCK, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
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69
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ITEM 6.
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SELECTED FINANCIAL DATA
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74
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ITEM 7.
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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76
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ITEM 7A.
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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92
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ITEM 8.
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FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
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93
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ITEM 9.
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CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
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93
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ITEM 9A.
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CONTROLS AND PROCEDURES
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94
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ITEM 9B.
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OTHER INFORMATION
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95
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ITEM 10.
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DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
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96
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ITEM 11.
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EXECUTIVE COMPENSATION
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106
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ITEM 12.
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
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116
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ITEM 13.
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CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
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119
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ITEM 14.
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PRINCIPAL ACCOUNTANT FEES AND SERVICES
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120
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ITEM 15.
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EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
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122
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SIGNATURES
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125
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ITEM 1. BUSINESS.
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I.
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The patient selection criteria of this study is highly selective. The participants enrolled in the studies were advanced, relapsed, and refractory to other standard-of-care therapies. This selection criterion is highly distinguishable from other studies, which avoided higher risk patients. Most of these high severity patients would not have been eligible for other entities’ studies because of extramedullary involvement or because the presence of bulky tumors were deemed too risky for their trials.
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II.
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The treatment program design of this study is very stringent.
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a.
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Our higher risk patients did not receive conditioning chemotherapy, which is known as a beneficial facilitator of adoptive T cell therapies.
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b.
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Moreover, our higher risk patients did not receive subsequent Hematopoietic Stem Cell transplantation (HSCT), which is also known as a beneficial facilitator of adoptive T cell therapies.
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●
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First known report of positive safety and signal of clinical activity of EGFR CAR-T in multiple solid tumor indications,
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●
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Most NSCLC patients treated with CBM-EGFR.1 failed EGFR-TKI therapy prior to CBM-EGFR.1 treatment,
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●
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Overall disease control rate (DCR) is 79% (19 of 24). 100% DCR in cholangiocarcinoma (5/5), 71% DCR in NSCLC (12/17),
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●
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Objective response rate (ORR) of 25% in combined indications: 2 complete response (CR) and 1 partial response (PR) in cholangiocarcinoma, 2 PR in NSCLC and 1 PR in pancreatic cancer.
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● | Confirm the safety and tolerability profile of CBM-EGFR.1 in cholangiocarcinoma and NSCLC; |
● | Explore the CBM-EGFR.1 opportunities in other solid tumor indications; |
● | Seek early possibilities of conducting multi-center Phase IIb trials to validate the clinical activity from early CBM-EGFR.1 observation; |
● | Confirm the safety and tolerability profile of CBM-CD20.1 targeting CD20 for NHL; |
● | Explore the CBM-CD20.1 opportunities in other cancer indications; |
● | Seek early possibilities of conducting multi-center Phase IIb trials to validate the clinical activity from early CBM-CD20.1 observation; |
● | Evaluate potential partners to develop an immunohistochemistry based diagnostic assay to aid in the patient selection whenever needed; |
● | Launch Phase II trials to explore the efficacy and safety of CD19 or CD20 CAR-T mono or combination therapies in chemo refractory/relapsing patients with hematological malignancies; |
● | File new CAR-T and other patents; |
● | Obtain approval for pending patents; |
● | Evaluate the feasibility of sponsoring a multi-sites Phase I/II clinical study to support the New Drug Application (NDA) for the U.S. CD40LGVAX trial; |
● | Evaluate feasibility of sponsoring a registration trial-like clinical study to support the New Drug Application (NDA) for an allogeneic haMPC Knee Osteoarthritis therapy (“Allo KOA”) study in the United States; |
● | Complete preclinical GLP safety evaluation studies of haMPC for Asthma and Chronic Obstructive Pulmonary Disease (COPD); |
● | Provide update on Cartilage Damage clinical study; |
● | Develop preclinical package for allogeneic haMPC therapy for COPD/Asthma clinical trial; |
● | Continue to seek advanced technologies to bolster our CAR-T China market position; |
● | Bolster R&D resources to fortify our intellectual properties portfolio and scientific development; |
● | File registration for our 2014 Stock Option Plan; and |
● | Improve liquidity by registering the shares sold in previous private placements and further fortify our balance sheet by courting institutional investors. |
●
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Obtain adipose (fat) tissue from the patient using our CFDA approved medical device, the A-Stromal
TM
Kit; and
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●
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Expand haMPCs using our proprietary culture medium (serum-free and antibiotics-free); and
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●
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formulated for ReJoin
TM
therapy using our proprietary formulation.
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● |
Banking processes that ensure cell preservation and viability;
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●
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DNA identification for stem cell ownership; and
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●
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Bio-safety testing at independently certified laboratories.
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●
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Cell Therapy. Cell therapy involves the use of cells, whether derived from adults, third party donors or patients, from various parts of the body, for the treatment of diseases or injuries. Therapeutic applications may include cancer vaccines, cell based immune-therapy, arthritis, heart disease, diabetes, Parkinson’s and Alzheimer’s diseases, vision impairments, orthopedic diseases and brain or spinal cord injuries. This subfield also includes the development of growth factors and serums and natural reagents that promote and guide cell development.
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●
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Tissue Engineering. This subfield involves using a combination of cells with biomaterials (also called “scaffolds”) to generate partially or fully functional tissues and organs, or using a mixture of technology in a bioprinting process. Some natural materials, like collagen, can be used as biomaterial, but advances in materials science have resulted in a variety of synthetic polymers with attributes that would make them uniquely attractive for certain applications. Therapeutic applications may include heart patch, bone re-growth, wound repair, replacement neo-urinary conduits, saphenous arterial grafts, inter-vertebral disc and spinal cord repair.
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●
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Diagnostics and Lab Services. This subfield involves the production and derivation of cell lines that may be used for the development of drugs and treatments for diseases or genetic defects. This sector also includes companies developing devices that are designed and optimized for regenerative medicine techniques, such as specialized catheters for the delivery of cells, tools for the extraction of stem cells and cell-based diagnostic tools.
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●
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We believe our intellectual property portfolio for haMPC is well-built and abundant. It covers aspects of adipose stem cell medicine production, including acquisition of human adipose tissue, preservation, and storage, tissue, processing, stem cell purification, expansion, and banking, formulation for administration, and administration methods.
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●
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Our portfolio also includes adipose derived cellular medicine formulations and their applications in the potential treatment of degenerative diseases and autoimmune diseases, including osteoarthritis, rheumatoid arthritis, as well as potential applications to anti-aging.
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●
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Our haMPC intellectual property portfolio:
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°
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provides coverage of all steps in the production process;
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°
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enables achievement of high yields of Stromal Vascular Fraction (SVF), i.e. stem cells derived from adipose tissue extracted by liposuction;
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°
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makes adipose tissue acquisition convenient and useful for purposes of cell banking; and
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°
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employs preservation techniques enabling long distance shipment of finished cell medicine products.
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●
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Our recent amalgamation of technologies from AGand PLAGH in the cancer cell therapy is comprehensive and well-rounded. It comprises of T cell clonality, Chimeric Antigen Receptor T cell (CAR-T) therapy, its recombinant expression vector CD19, CD20, CD30 and Human Epidermal Growth Factor Receptor's (EGFR or HER1) Immuno-Oncology patents applications, several preliminary clinical studies of various CAR-T constructs targeting CD19-positive acute lymphoblastic leukemia, CD20-positive lymphoma, CD30-positive Hodgkin's lymphoma and EGFR-HER1-positive advanced lung cancer, and Phase I/II clinical data of the aforementioned therapies and manufacturing knowledge.
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China Patents
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U.S. Patents
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EU Patents
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Other International Patents
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PCT
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||||||||||||||||
Work in Process
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6 | - | - | - | - | |||||||||||||||
Patents Filed, Pending
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23 | 2 | 2 | 2 | 4 | |||||||||||||||
Granted
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18 | 1 | - | - | - | |||||||||||||||
Total
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47 | 3 | 2 | 2 | 4 |
●
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Subject to prior review by the ethics committees of participating hospitals;
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Sponsors would be required to submit informed consent forms, a safety evaluation, research protocols and information concerning the qualifications of the principal investigators;
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Sponsors would be required to submit information concerning the production of the investigational stem cell products; and
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●
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Only hospitals certified by the MOH and affiliates would be allowed to serve as sites for such trials.
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ITEM 1A.
Risk Factors
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●
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Educating medical personnel regarding the application protocol;
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●
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Sourcing clinical and commercial supplies for the materials used to manufacture and process our Tcm product candidates;
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● |
Developing a consistent and reliable process, while limiting contamination risks regarding the application protocol;
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● |
Conditioning patients with chemotherapy in conjunction with delivering Tcm treatment, which may increase the risk of adverse side effects;
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● |
Obtaining regulatory approval, as the Chinese Food and Drug Administration, or CFDA, and other regulatory authorities have limited experience with commercial development of cell-based therapies, and therefore the pathway to regulatory approval may be more complex and require more time than we anticipate; and
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●
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Establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy.
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●
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survive and persist in the desired location;
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●
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provide the intended therapeutic benefit;
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●
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engraft or integrate into existing tissue in the desired manner; or
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●
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achieve therapeutic benefits equal to, or better than, the standard of treatment at the time of testing.
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●
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the clinical safety and effectiveness of the product candidates, the availability of alternative treatments and the perceived advantages of the particular product candidates over alternative treatments;
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●
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the relative convenience and ease of administration of the product candidates;
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●
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our ability to separate the product candidates from the ethical controversies and political barriers associated with stem cell product candidates derived from human embryonic or fetal tissue;
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●
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ethical concerns that may arise regarding our commercial use of stem cells, including adult stem cells, in the manufacture of the product candidates;
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●
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the frequency and severity of adverse events or other undesirable side effects involving the product candidates or the products or product candidates of others that are cell-based; and
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●
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the cost of the products, the reimbursement policies of government and third-party payors and our ability to obtain sufficient third-party coverage or reimbursement.
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●
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regulators or institutional review boards may not authorize us or our investigators to commence clinical trials or conduct clinical trials at a prospective trial site;
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●
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clinical trials of product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs that we expect to be pursuing;
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●
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the number of patients required for clinical trials of product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;
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●
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third party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;
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●
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we might have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks;
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●
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regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
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●
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the cost of clinical trials of our product candidates may be greater than anticipated;
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●
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we may be subject to a more complex regulatory process, since cell-based therapies are relatively new and regulatory agencies have less experience with them as compared to traditional pharmaceutical products;
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●
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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of these product candidates may be insufficient or inadequate; and
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●
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our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to halt or terminate the trials.
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the patient eligibility criteria defined in the protocol;
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the size of the patient population required for analysis of the trial’s primary endpoints;
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the proximity of patients to study sites;
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●
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the design of the trial;
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●
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our ability to recruit clinical trial investigators with the appropriate competencies and experience;
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●
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our ability to obtain and maintain patient consents; and
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●
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the risk that patients enrolled in clinical trials will drop out of the trials before completion.
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●
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the demand for our product candidates, if we obtain regulatory approval;
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● |
our ability to set a price that we believe is fair for our products;
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●
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our ability to generate revenue and achieve or maintain profitability;
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the level of taxes that we are required to pay; and
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●
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the availability of capital.
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●
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Failure to successfully manage relationships with hospitals, patients and suppliers;
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Demands on management related to the increase in complexity of the company after the acquisition;
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Diversion of management and scientists’ attention;
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Potential difficulties integrating and harmonizing large scale multi-site clinical trials;
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Difficulties in the assimilation and retention of employees;
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Exposure to legal claims for activities of the acquired technologies; and
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●
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Incurrence of additional expenses in connection with the integration process.
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●
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identifying, recruiting, integrating, maintaining and motivating additional employees;
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managing our internal development efforts effectively, including the clinical trials and CFDA review process for our product candidates, while complying with our contractual obligations to contractors and other third parties; and
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improving our operational, financial and management controls, reporting systems and procedures.
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the scope, progress, results, costs, timing and outcomes of our other cell therapy product or therapy candidates;
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●
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our ability to enter into, or continue, any collaboration agreements with third parties for our product or therapy candidates and the timing and terms of any such agreements;
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the timing of and the costs involved in obtaining regulatory approvals for our product or therapy candidates, a process which could be particularly lengthy or complex given the lack of precedent for cell therapy products in China; and
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●
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the costs of maintaining, expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities.
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our inability to enforce or obtain a remedy under any material agreements;
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PRC restrictions on foreign investment that could impair our ability to conduct our business or acquire or contract with other entities in the future;
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●
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restrictions on currency exchange that may limit our ability to use cash flow most effectively or to repatriate our investment;
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●
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fluctuations in currency values;
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●
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cultural, language and managerial differences that may reduce our overall performance; and
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●
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political instability in China.
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●
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a limited availability of market quotations for our securities;
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● |
reduced liquidity for our securities;
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●
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a determination that our common stock is "penny stock" which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
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● |
a limited amount of news and analyst coverage; and
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●
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a decreased ability to issue additional securities or obtain additional financing in the future.
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ITEM 2.
PROPERTIES.
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ITEM 3.
LEGAL PROCEEDINGS
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ITEM 5.
MARKET FOR REGISTRANT'S COMMON STOCK, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
|
High
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Low
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|||||||
Fiscal Year 2015
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||||||||
First Quarter (January – March 2015)
|
$ | 49.00 | $ | 12.93 | ||||
Second Quarter (April – June 2015)
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$ | 41.73 | $ | 21.41 | ||||
Third Quarter (July – September 2015)
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$ | 38.74 | $ | 16.00 | ||||
Fourth Quarter (October – December 2015)
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$ | 25.20 | $ | 15.90 | ||||
Fiscal Year 2014
|
||||||||
First Quarter (January – March 2014)
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$ | 5.59 | $ | 5.00 | ||||
Second Quarter (April – June 2014)
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$ | 15.25 | $ | 4.51 | ||||
Third Quarter (July – September 2014)
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$ | 35.45 | $ | 14.27 | ||||
Fourth Quarter (October – December 2014)
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$ | 19.20 | $ | 11.52 |
Number of securities
to be issued
warrants and rights (#)
|
Weighted-average
exercise price of
|
Number of securities
remaining available
equity compensation plans
|
||||||||||
Equity compensation plans approved by stockholders
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2,030,648 | $ | 11.94 | 498,495 | ||||||||
Equity compensation plans not approved by stockholders
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- | - | - | |||||||||
Total
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2,030,648 | $ | 11.94 | 498,495 |
2010
|
2011
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2012
|
2013
|
2014
|
2015
|
|||||||||||||||||||
CBMG Inc.
|
$ | 100.00 | $ | 52.08 | $ | 40.63 | $ | 53.13 | $ | 134.48 | $ | 223.85 | ||||||||||||
Nasdaq Healthcare Index (^IXHC)
|
$ | 100.00 | $ | 104.51 | $ | 132.98 | $ | 208.83 | $ | 268.28 | $ | 286.68 | ||||||||||||
Russell 3000 Index (RUA)
|
$ | 100.00 | $ | 101.03 | $ | 117.61 | $ | 157.07 | $ | 176.79 | $ | 177.64 | ||||||||||||
1 | 2 | 3 | ||||||||||||||||||||||
Notes
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||||||||||||||||||||||||
1. CBMG merged with Eastbridge Investment Group Corp. (OTCQB: EBIG), a consulting company on February 6, 2013. Trading symbol changed to CBMG on March 5, 2013
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2. CBMG uplisted from OTCQB to Nasdaq on June 26, 2014
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3. CBMG included as part of the Russell 3000 index on June 16, 2015
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ITEM 6.
SELECTED FINANCIAL DATA
|
For the Year Ended
December 31,
|
||||||||||||||||||||
2015
|
2014
|
2013
|
2012
|
2011
|
||||||||||||||||
Summary
Consolidated statement of operations and comprehensive loss data:
|
||||||||||||||||||||
Net sales and revenue
|
$ | 2,505,423 | $ | 564,377 | $ | 204,914 | $ | 273,620 | $ | 198,489 | ||||||||||
Operating expenses:
|
||||||||||||||||||||
Cost of sales
|
1,880,331 | 242,215 | 296,212 | 194,264 | 99,694 | |||||||||||||||
General and administrative
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13,068,255 | 7,875,413 | 9,162,172 | 3,455,444 | 1,282,029 | |||||||||||||||
Selling and marketing
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709,151 | 314,894 | 58,275 | 471,420 | 140,728 | |||||||||||||||
Research and development
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7,573,228 | 3,146,499 | 2,041,872 | 3,214,289 | 228,462 | |||||||||||||||
Impairment of investments
|
123,428 | 1,427,840 | - | |||||||||||||||||
Total operating expenses
|
23,354,393 | 13,006,861 | 11,558,531 | 7,335,417 | 1,750,913 | |||||||||||||||
Operating loss
|
(20,848,970 | ) | (12,442,484 | ) | (11,353,617 | ) | (7,061,797 | ) | (1,552,424 | ) | ||||||||||
Other income (expense):
|
||||||||||||||||||||
Interest income
|
42,220 | 15,043 | 1,294 | 1,788 | 1,457 | |||||||||||||||
Other income (expense)
|
630,428 | 71,982 | (6,196 | ) | 28,492 | (42,106 | ) | |||||||||||||
Total other income (expense)
|
672,648 | 87,025 | (4,902 | ) | 30,280 | (40,649 | ) | |||||||||||||
Loss from continuing operations before taxes
|
(20,176,322 | ) | (12,355,459 | ) | (11,358,519 | ) | (7,031,517 | ) | (1,593,073 | ) | ||||||||||
Income taxes (expense) credit
|
728,601 | - | - | - | - | |||||||||||||||
Loss from continuing operations
|
(19,447,721 | ) | (12,355,459 | ) | (11,358,519 | ) | (7,031,517 | ) | (1,593,073 | ) | ||||||||||
Loss on discontinued operations, net of taxes
|
- | (3,119,152 | ) | (2,438,514 | ) | - | - | |||||||||||||
Net loss
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (13,797,033 | ) | $ | (7,031,517 | ) | $ | (1,593,073 | ) | |||||
Other comprehensive income (loss):
|
||||||||||||||||||||
Cumulative translation adjustment
|
(307,950 | ) | 15,254 | 78,650 | 13,705 | 36,620 | ||||||||||||||
Unrecognized gain (loss) on investments
|
(1,376,540 | ) | 1,611,045 | (198,200 | ) | - | - | |||||||||||||
Total other comprehensive income (loss):
|
(1,684,490 | ) | 1,626,299 | (119,550 | ) | 13,705 | 36,620 | |||||||||||||
Comprehensive loss
|
$ | (21,132,211 | ) | $ | (13,848,312 | ) | $ | (13,916,583 | ) | $ | (7,017,812 | ) | $ | (1,556,453 | ) | |||||
Net loss per share :
|
||||||||||||||||||||
Basic
|
$ | (1.70 | ) | $ | (1.79 | ) | $ | (2.38 | ) | $ | (2.24 | ) | $ | (1.15 | ) | |||||
Diluted
|
$ | (1.70 | ) | $ | (1.79 | ) | $ | (2.38 | ) | $ | (2.24 | ) | $ | (1.15 | ) | |||||
Weighted average common shares outstanding:
|
||||||||||||||||||||
Basic
|
11,472,306 | 8,627,094 | 5,792,888 | 3,134,833 | 1,389,000 | |||||||||||||||
Diluted
|
11,472,306 | 8,627,094 | 5,792,888 | 3,134,833 | 1,389,000 |
As of
December 31,
|
||||||||||||||||||||
2015 | 2014 | 2013 | 2012 | 2011 | ||||||||||||||||
Summary
Consolidated balance sheet data:
|
||||||||||||||||||||
Cash and cash equivalents
|
$ | 14,884,597 | $ | 14,770,584 | $ | 7,175,215 | $ | 4,144,896 | $ | 4,413,971 | ||||||||||
Current working capital (1)
|
13,675,034 | 12,019,143 | 5,373,355 | 3,754,386 | 2,287,969 | |||||||||||||||
Total assets
|
49,460,422 | 43,685,102 | 17,596,726 | 6,751,627 | 5,802,367 | |||||||||||||||
Other non-current liabilities
|
76,229 | 452,689 | - | - | - | |||||||||||||||
Stockholders’ equity
|
46,364,936 | 39,156,091 | 15,395,073 | 6,156,394 | 2,811,478 | |||||||||||||||
(1)
|
The Company was originally incorporated in the State of Arizona on June 25, 2001 under the name ATC Technology Corporation. ATC Technology Corporation changed its corporate name to EastBridge Investment Group Corporation in September 2005 and changed its business focus to providing investment related services in Asia. On November 13, 2012, EastBridge Investment Group Corporation, an Arizona corporation (“EastBridge”), CBMG Acquisition Limited, a British Virgin Islands company and the Company’s wholly-owned subsidiary (“Merger Sub”) and Cellular Biomedicine Group Ltd. (“CBMG BVI”), a British Virgin Islands company, entered into a Merger Agreement, pursuant to which CBMG BVI was the surviving entity in a merger with Merger Sub whereby CBMG BVI became a wholly-owned subsidiary of the Company (the “Merger”). The Merger was consummated on February 6, 2013 (the “Closing Date”). In connection with the Merger, effective March 5, 2013, the Company (formerly named “EastBridge Investment Group Corporation”) changed its name to “Cellular Biomedicine Group, Inc.” CBMG BVI was the accounting acquirer and resulted in a reverse merger. The consolidated balance sheet data as of December 31, 2012 and 2011 and the consolidated statement of operation and comprehensive income data for the year then ended represents the historical financial data of the acquirer - CBMG BVI.
|
(2)
|
Current working capital is the difference between total current assets and total current liabilities.
|
ITEM 7.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
|
Year Ended December 31, 2015
|
Year Ended December 31, 2014
|
Year Ended December 31, 2013
|
||||||||||||||||||||||||||
CBMG
|
CBMG
|
Agreen
|
Pro forma
|
CBMG
|
Agreen
|
Pro forma
|
||||||||||||||||||||||
As stated
|
As stated
|
Pro forma Adjustment
|
Consolidated
|
As stated
|
Pro forma Adjustment
|
Consolidated
|
||||||||||||||||||||||
Net sales and revenue
|
$ | 2,505,423 | $ | 564,377 | $ | 1,198,414 | $ | 1,762,791 | $ | 204,914 | $ | 1,075,692 | $ | 1,280,606 | ||||||||||||||
Operating expenses:
|
||||||||||||||||||||||||||||
Cost of sales *
|
1,880,331 | 242,215 | 880,797 | 1,123,012 | 296,212 | 872,937 | 1,169,149 | |||||||||||||||||||||
General and administrative *
|
13,068,255 | 7,875,413 | 245,911 | 8,121,324 | 9,162,172 | 304,027 | 9,466,199 | |||||||||||||||||||||
Selling and marketing *
|
709,151 | 314,894 | 6,351 | 321,245 | 58,275 | 9,709 | 67,984 | |||||||||||||||||||||
Research and development *
|
7,573,228 | 3,146,499 | 113,635 | 3,260,134 | 2,041,872 | 214,752 | 2,256,624 | |||||||||||||||||||||
Impairment of investments
|
123,428 | 1,427,840 | - | 1,427,840 | - | - | - | |||||||||||||||||||||
Total operating expenses
|
23,354,393 | 13,006,861 | 1,246,694 | 14,253,555 | 11,558,531 | 1,401,425 | 12,959,956 | |||||||||||||||||||||
Operating loss
|
(20,848,970 | ) | (12,442,484 | ) | (48,280 | ) | (12,490,764 | ) | (11,353,617 | ) | (325,733 | ) | (11,679,350 | ) | ||||||||||||||
Other income (expense)
|
||||||||||||||||||||||||||||
Interest income
|
42,220 | 15,043 | 318 | 15,361 | 1,294 | 310 | 1,604 | |||||||||||||||||||||
Other income (expense)
|
630,428 | 71,982 | (147 | ) | 71,835 | (6,196 | ) | (13,381 | ) | (19,577 | ) | |||||||||||||||||
Total other income (expense)
|
672,648 | 87,025 | 171 | 87,196 | (4,902 | ) | (13,071 | ) | (17,973 | ) | ||||||||||||||||||
Loss from continuing operations before taxes
|
(20,176,322 | ) | (12,355,459 | ) | (48,109 | ) | (12,403,568 | ) | (11,358,519 | ) | (338,804 | ) | (11,697,323 | ) | ||||||||||||||
Income taxes (expense) credit
|
728,601 | - | - | - | - | - | - | |||||||||||||||||||||
Loss from Continuing operations
|
(19,447,721 | ) | (12,355,459 | ) | (48,109 | ) | (12,403,568 | ) | (11,358,519 | ) | (338,804 | ) | (11,697,323 | ) | ||||||||||||||
Loss on discontinued operations, net of taxes
|
- | (3,119,152 | ) | - | (3,119,152 | ) | (2,438,514 | ) | - | (2,438,514 | ) | |||||||||||||||||
Net loss
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (48,109 | ) | $ | (15,522,720 | ) | $ | (13,797,033 | ) | $ | (338,804 | ) | $ | (14,135,837 | ) | |||||||
Other comprehensive income (loss):
|
||||||||||||||||||||||||||||
Cumulative translation adjustment
|
(307,950 | ) | 15,254 | 963 | 16,217 | 78,650 | (9,627 | ) | 69,023 | |||||||||||||||||||
Unrecognized gain (loss) on investments
|
(1,376,540 | ) | 1,611,045 | - | 1,611,045 | (198,200 | ) | - | (198,200 | ) | ||||||||||||||||||
Total other comprehensive income (loss):
|
(1,684,490 | ) | 1,626,299 | 963 | 1,627,262 | (119,550 | ) | (9,627 | ) | (129,177 | ) | |||||||||||||||||
Comprehensive income (loss)
|
$ | (21,132,211 | ) | $ | (13,848,312 | ) | $ | (47,146 | ) | $ | (13,895,458 | ) | $ | (13,916,583 | ) | $ | (348,431 | ) | $ | (14,265,014 | ) | |||||||
Loss per share for continuing operations:
|
||||||||||||||||||||||||||||
Basic
|
$ | (1.70 | ) | $ | (1.43 | ) | $ | (0.09 | ) | $ | (1.35 | ) | $ | (1.96 | ) | $ | (0.45 | ) | $ | (1.79 | ) | |||||||
Diluted
|
$ | (1.70 | ) | $ | (1.43 | ) | $ | (0.09 | ) | $ | (1.35 | ) | $ | (1.96 | ) | $ | (0.45 | ) | $ | (1.79 | ) | |||||||
Loss per share for discontinued operations:
|
||||||||||||||||||||||||||||
Basic
|
$ | - | $ | (0.36 | ) | $ | - | $ | (0.34 | ) | $ | (0.42 | ) | $ | - | $ | (0.37 | ) | ||||||||||
Diluted
|
$ | - | $ | (0.36 | ) | $ | - | $ | (0.34 | ) | $ | (0.42 | ) | $ | - | $ | (0.37 | ) | ||||||||||
Net loss per share:
|
||||||||||||||||||||||||||||
Basic
|
$ | (1.70 | ) | $ | (1.79 | ) | $ | (0.09 | ) | $ | (1.69 | ) | $ | (2.38 | ) | $ | (0.45 | ) | $ | (2.16 | ) | |||||||
Diluted
|
$ | (1.70 | ) | $ | (1.79 | ) | $ | (0.09 | ) | $ | (1.69 | ) | $ | (2.38 | ) | $ | (0.45 | ) | $ | (2.16 | ) | |||||||
Weighted average common shares outstanding:
|
||||||||||||||||||||||||||||
Basic
|
11,472,306 | 8,627,094 | 555,335 | 9,182,429 | 5,792,888 | 753,522 | 6,546,410 | |||||||||||||||||||||
Diluted
|
11,472,306 | 8,627,094 | 555,335 | 9,182,429 | 5,792,888 | 752,522 | 6,545,410 | |||||||||||||||||||||
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 2,505,423 | $ | 564,377 | $ | 204,914 | $ | 1,941,046 | 344 | % | $ | 359,463 | 175 | % |
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 1,880,331 | $ | 242,215 | $ | 296,212 | $ | 1,638,116 | 676 | % | $ | (53,997 | ) | (18 | )% | |||||||||||||
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 13,068,255 | $ | 7,875,413 | $ | 9,162,172 | $ | 5,192,842 | 66 | % | $ | (1,286,759 | ) | (14 | )% | |||||||||||||
●
|
An increase in stock-based compensation expense of $3,744,000, which primarily resulted from the new grants and higher fair value of unvested options in 2015 after the Company listed on Nasdaq in June 2014 compared with those unvested options as of December 31, 2014;
|
●
|
An increase in payroll of $314,000 in line with the headcount increase in management in 2015.;
|
●
|
An increase in depreciation and amortization of $235,000, which was mainly attributed to the knowhow and patents obtained from the acquisition of AG in third quarter 2014;
|
●
|
An increase in rental, property management and utility expenses of $466,000, which was mainly attributed to the new lease agreement concluded for the construction of Beijing GMP;
|
●
|
An increase in travelling expenses of $166,000; and
|
●
|
An increase in legal and other professional services of $101,000.
|
●
|
Expenses associated with increased corporate activities related to the effects of our Merger in 2013:
|
°
|
A decrease in legal, professional and accounting services of $1,022,000;
|
°
|
A decrease in investor relations expense of $1,503,000, which mainly due to the Company issued 342,360 shares of common stock to specific stockholders and expensed $1,694,682 in connection with these issuances as the Company did not achieve ten Phase II clinical trials by March 31, 2013 in accordance with the terms and conditions of certain private placement agreements entered into by private investors in CBMG BVI and assumed by the Company; partially offset by
|
●
|
An increase in payroll expenses of $330,000;
|
●
|
An increase in depreciation expense of $264,000;
|
●
|
An increase in loss on disposal of asset of $222,000
|
●
|
An increase in other expenses of $139,000;
|
●
|
An increase in travel expense of $179,000; and
|
●
|
An increase in rent expense of $116,000.
|
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 709,151 | $ | 314,894 | $ | 58,275 | $ | 394,257 | 125 | % | $ | 256,619 | 440 | % |
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 7,573,228 | $ | 3,146,499 | $ | 2,041,872 | $ | 4,426,729 | 141 | % | $ | 1,104,627 | 54 | % |
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 123,428 | $ | 1,427,840 | $ | - | $ | (1,304,412 | ) | (91 | )% | $ | 1,427,840 | 0 | % |
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | (20,848,970 | ) | $ | (12,442,484 | ) | $ | (11,353,617 | ) | $ | (8,406,486 | ) | 68 | % | $ | (1,088,867 | ) | 10 | % | |||||||||
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 672,648 | $ | 87,025 | $ | (4,902 | ) | $ | 585,623 | 673 | % | $ | 91,927 | (1875 | )% | |||||||||||||
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | 728,601 | $ | - | $ | - | $ | 728,601 | 0 | % | $ | - | 0 | % | ||||||||||||||
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | (19,447,721 | ) | $ | (12,355,459 | ) | $ | (11,358,519 | ) | $ | (7,092,262 | ) | 57 | % | $ | (996,940 | ) | 9 | % |
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | - | $ | (3,119,152 | ) | $ | (2,438,514 | ) | $ | 3,119,152 | (100 | )% | $ | (680,638 | ) | 28 | % | |||||||||||
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (13,797,033 | ) | $ | (3,973,110 | ) | 26 | % | $ | (1,677,578 | ) | 12 | % |
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||||||||||
2015
|
2014
|
2013
|
Change
|
Percent
|
Change
|
Percent
|
||||||||||||||||||||||
Year ended December 31,
|
$ | (21,132,211 | ) | $ | (13,848,312 | ) | $ | (13,916,583 | ) | $ | (7,283,899 | ) | 53 | % | $ | 68,271 | 0 | % |
Shares
|
Unrealised Share-Based Compensation Costs
|
Weighted Average Period
|
|||||||
Non-vested stock options
|
1,092,204 | $ | 12,977,214 |
1.68 year
|
|||||
Non-vested restricted stock
|
78,000 | $ | 1,744,171 |
1.79 year
|
2015 versus 2014
|
2014 versus 2013
|
|||||||||||||||||||
For year ended December 31,
|
2015
|
2014
|
2013
|
Change
|
Change
|
|||||||||||||||
Net loss
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (13,797,033 | ) | $ | (3,973,110 | ) | $ | (1,677,578 | ) | |||||
Income statement reconciliation items
|
9,595,098 | 7,100,381 | 6,126,978 | 2,494,717 | 973,403 | |||||||||||||||
Changes in operating assets, net
|
(1,898,475 | ) | (1,346,662 | ) | (785,309 | ) | (551,813 | ) | (561,353 | ) | ||||||||||
Net cash used in operating activities
|
$ | (11,751,098 | ) | $ | (9,720,892 | ) | $ | (8,455,364 | ) | $ | (2,030,206 | ) | $ | (1,265,528 | ) |
Payments due by period
|
|||||||||||||||||
Contractual Obligations
|
Total
|
Less than
1 year
|
1-3
years
|
3-5
years
|
More than
5 years
|
||||||||||||
Capital Commitment
|
$ |
193,373
|
$ |
193,373
|
-
|
-
|
-
|
||||||||||
Operating Lease Obligations
|
$ |
3,049,009
|
$ |
1,015,863
|
$ |
960,401
|
$ |
680,235
|
$392,510
|
||||||||
Total
|
$ |
3,242,382
|
$ |
1,209,236
|
$ |
960,401
|
$ |
680,235
|
$392,510
|
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Exposure to foreign currencies (Expressed in USD)
|
||||||||
As of December 31, 2015
|
||||||||
RMB
|
USD
|
|||||||
Cash and cash equivalents
|
3,905,460 | 382,222 | ||||||
Net exposure arising from recognised assets and liabilities
|
3,905,460 | 382,222 |
As of December 31, 2015
|
||||||||
Increase/(decrease) in foreign exchange rates |
Effect on net loss (Expressed in USD)
|
|||||||
RMB (against USD)
|
5 | % | 176,162 | |||||
-5 | % | (176,162 | ) |
ITEM 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
|
ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
|
ITEM 9A.
CONTROLS AND PROCEDURES
|
ITEM 9B.
OTHER INFORMATION
|
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
|
Class
|
Term
|
||
Class I
|
Class I directors serve for a term of three years, and are elected by the stockholders at the beginning of each term. The full 3-year term for Class I directors extends from the date of the 2013 Annual Meeting of stockholders to the date of the 2016 annual meeting.
|
||
Class II
|
Class II directors serve for a term of three years, and are elected by the stockholders at the beginning of each term. The full 3-year term for Class II directors extends from the date of the 2014 annual meeting to the date of the 2017 annual meeting.
|
||
Class III
|
Class III directors serve for a term of three years, and are elected by the stockholders at the beginning of each term. The full 3-year term for Class III directors extends from the date of the 2015 annual meeting to the date of the 2018 annual meeting.
|
Name
|
Age
|
Position
|
Term
|
||||||||||
Wen Tao (Steve) Liu
|
60
|
Director
|
Class III
|
||||||||||
Wei (William) Cao
|
57
|
Director
|
Class III
|
||||||||||
Tony (Bizuo) Liu
|
51
|
Chief Executive Officer, Chief Financial Officer and Secretary
|
Class II
|
||||||||||
Chun Kwok Alan Au (2)(3)
|
44
|
Independent Director
|
Class II
|
||||||||||
Guotong Xu(2)
|
58
|
Independent Director
|
Class II
|
||||||||||
Gerardus A. Hoogland
|
60
|
Non-independent Director
|
Class I
|
||||||||||
David Bolocan (1)(2)
|
51
|
Independent Director
|
Class I
|
||||||||||
Terry A. Belmont (1
)(3)
|
70
|
Chairman of the Board and Independent Director
|
Class I
|
||||||||||
Nadir Patel (1)(3)
|
46
|
Independent Director
|
Class III
|
||||||||||
Richard Wang
|
54
|
Chief Operating Officer
|
N/A
|
||||||||||
Yihong Yao
|
48
|
Chief Scientific Officer
|
N/A
|
||||||||||
(1)
|
Member of Audit Committee
|
(2)
|
Member of Compensation Committee
|
(3)
|
Member of Nominating and Corporate Governance Committee
|
Name
|
Audit Committee
|
Compensation Committee
|
Nominating & Corporate Governance Committee
|
Nadir Patel
|
Chair
|
X
|
|
Terry A. Belmont
|
X
|
Chair
|
|
David Bolocan
|
X
|
Chair
|
|
Chun Kwok Alan Au
|
X
|
X
|
|
Guotong Xu
|
X
|
●
|
oversee management’s preparation of our financial statements and management’s conduct of the accounting and financial reporting processes;
|
●
|
oversee management’s maintenance of internal controls and procedures for financial reporting;
|
●
|
oversee our compliance with applicable legal and regulatory requirements, including without limitation, those requirements relating to financial controls and reporting;
|
●
|
oversee the independent auditor’s qualifications and independence;
|
●
|
oversee the performance of the independent auditors, including the annual independent audit of our financial statements;
|
●
|
discharge such duties and responsibilities as may be required of the Audit Committee by the provisions of applicable law, rule or regulation.
|
●
|
develop and recommend to the Board the annual compensation (base salary, bonus, stock options and other benefits) for our President/Chief Executive Officer;
|
●
|
review, approve and recommend to the Board the annual compensation (base salary, bonus and other benefits) for all of our executives;
|
●
|
review, approve and recommend to the Board the aggregate number of equity awards to be granted to employees below the executive level;
|
●
|
ensure that a significant portion of executive compensation is reasonably related to the long-term interest of our stockholders; and
|
●
|
prepare certain portions of our annual Proxy Statement, including an annual report on executive compensation.
|
●
|
evaluate from time to time the appropriate size (number of members) of the Board and recommend any increase or decrease;
|
●
|
determine the desired skills and attributes of members of the Board and its committees, taking into account the needs of the business and listing standards;
|
●
|
establish criteria for prospective members, conduct candidate searches, interview prospective candidates, and oversee programs to introduce the candidate to us, our management, and operations;
|
●
|
review planning for succession to the position of Chairman of the Board and Chief Executive Officer and other senior management positions;
|
●
|
annually recommend to the Board persons to be nominated for election as directors and appointment as members of committees;
|
●
|
adopt or develop for Board consideration corporate governance principles and policies; and
review and report to the Board on the effectiveness of corporate governance procedures and the Board as a governing body, including conducting an annual self-assessment of the Board and its standing committees.
|
●
|
periodically review and report to the Board on the effectiveness of corporate governance procedures and the Board as a governing body, including conducting an annual self-assessment of the Board and its standing committees.
|
ITEM 11.
EXECUTIVE COMPENSATION
|
Name and Principal Position
|
Year
|
Salary
|
Bonus
|
Stock
|
Option
|
Non-Equity
|
Nonqualified
|
All Other
|
Total
|
|||||||
($)
|
($)
|
Awards
|
Awards
|
Incentive Plan
|
Deferred
|
Compensation
|
($)
|
|||||||||
($)
|
($)
|
Compensation
|
Compensation
|
($)
|
||||||||||||
($)
|
Earnings
|
|||||||||||||||
($)
|
||||||||||||||||
Wen Tao (Steve) Liu, Director, Former President and Chairman of the Board
|
2015
|
150,000
|
-
|
-
|
697,860
|
-
|
-
|
-
|
847,860
|
|||||||
2014
|
200,004
|
-
|
37,727
|
-
|
-
|
-
|
-
|
237,731
|
||||||||
2013
|
168,750
|
33,750
|
-
|
472,770
|
-
|
-
|
-
|
675,270
|
||||||||
Wei (William) Cao, Director, Former Chief Executive Officer
|
2015
|
247,717
|
-
|
-
|
4,723,010
|
-
|
-
|
-
|
4,970,727
|
|||||||
2014
|
225,000
|
-
|
-
|
-
|
-
|
-
|
-
|
225,000
|
||||||||
2013
|
172,917
|
34,583
|
-
|
664,335
|
-
|
-
|
-
|
871,835
|
||||||||
Bizuo (Tony) Liu, Chief Financial Officer and Director
|
2015
|
226,750
|
-
|
-
|
3,507,780
|
-
|
-
|
-
|
3,734,530
|
|||||||
2014
|
155,491
|
-
|
-
|
1,141,712
|
-
|
-
|
-
|
1,297,203
|
||||||||
2013
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||
Andrew Chan, Senior Vice President, Corporate Business Development
|
2015
|
228,338
|
61,217
|
-
|
-
|
-
|
-
|
-
|
289,555
|
|||||||
2014
|
220,006
|
-
|
46,200
|
209,625
|
-
|
-
|
-
|
475,831
|
||||||||
2013
|
166,667
|
33,333
|
-
|
210,120
|
-
|
-
|
-
|
410,120
|
||||||||
Richard L. Wang, Chief Operating Officer
|
2015
|
128,461
|
-
|
590,800
|
659,100
|
-
|
-
|
-
|
1,378,361
|
|||||||
2014
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||
2013
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||
Yihong Yao, Chief Scientific Officer
|
2015
|
116,045
|
-
|
613,865
|
490,000
|
-
|
-
|
-
|
1,219,910
|
|||||||
2014
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||
2013
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
2015
|
2014
|
Change
|
|||||||
Revenue
|
$2.51 million
|
$0.56 million
|
Up 344%
|
||||||
Gross Margin
|
24.9 | % | 57.1 | % |
Down 32.2 points
|
||||
Operating Income (Loss)
|
($20.8 million)
|
($12.4 million)
|
Down 68%
|
||||||
Net Income (Loss)
|
($20 million)
|
($15.5 million)
|
Down 29.4%
|
||||||
Earnings/ (Loss) Per Share
|
$ | -1.74 | $ | -1.79 |
Up 2.9%
|
●
|
Expected volatility – 88.41% to 99.27%; and
|
●
|
Risk-free rate of return – 1.39% to 1.92% ; and
|
●
|
Dividend yield –zero; and
|
●
|
Time to exercise – six years.
|
Category
|
2015 Goals
|
|
Financials
|
Growth in Top Line and Gross Margin, management of approved budget, and maintenance of ample working capital
|
|
Corporate Development
|
Develop strategic partnership and acquisition of complementary technologies
|
|
Product Development
|
Manage Clinical Trials execution
|
2015 Base Salary
($)
|
2014 Base Salary
($)
|
Change
2015 vs 2014
|
||||||||||
William Cao | 247,717 | 225,000 | 10 | % | ||||||||
Tony Liu | 226,750 | 155,491 | 46 | % | ||||||||
Richard Wang | 128,461 | NA | NA | |||||||||
Yihong Yao | 116,045 | NA | NA | |||||||||
Steve Liu | 150,000 | 200,004 | -25 | % |
Name
|
Option awards
|
Stock awards
|
|||||||||||||||||||||||||||||||
Number of securities underlying unexercised options(#) exercisable
|
Number of securities underlying unexercised options (#) unexercisable
|
Equityincentive plan awards: Number of securities underlying unexercised unearned options (#)
|
Option exercise price ($)
|
Option expiration date
|
Number of shares or units of stock that have not vested(#)
|
Market value of shares of units of stock that have not vested($)
|
Equityincentive plan awards: Number of unearned shares, units or other rights that have not vested (#)
|
Equityincentive plan awards: Market or payout value of unearned shares, units or other rights that have not vested ($)
|
|||||||||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
||||||||||||||||||||||||
Wen Tao (Steve) Liu, President and Chairman of the Board (1)
|
138,520 | 8,147 | - | $ | 3.00 |
2/20/2023
|
- | - | - | - | |||||||||||||||||||||||
Wen Tao (Steve) Liu, President and Chairman of the Board (2)
|
11,222 | 22,445 | - | $ | 15.53 |
12/31/2021
|
- | - | - | - | |||||||||||||||||||||||
Wei (William) Cao, Chief Executive Officer and Director (3)
|
86,852 | 3,148 | - | $ | 3.00 |
2/20/2023
|
- | - | - | - | |||||||||||||||||||||||
Wei (William) Cao, Chief Executive Officer and Director (4)
|
47,500 | 22,500 | - | $ | 5.40 |
9/30/2023
|
- | - | - | - | |||||||||||||||||||||||
Wei (William) Cao, Chief Executive Officer and Director (5)
|
10,000 | 20,000 | $ | 20.63 |
7/23/2021
|
- | - | - | - | ||||||||||||||||||||||||
Wei (William) Cao, Chief Executive Officer and Director (6)
|
10,000 | 20,000 | $ | 20.63 |
8/14/2021
|
- | - | - | - | ||||||||||||||||||||||||
Wei (William) Cao, Chief Executive Officer and Director (7)
|
33,667 | 67,333 | $ | 15.53 |
12/31/2021
|
- | - | - | - | ||||||||||||||||||||||||
Wei (William) Cao, Chief Executive Officer and Director (8)
|
- | 60,000 | $ | 35.53 |
4/6/2025
|
- | - | - | - | ||||||||||||||||||||||||
Andrew Chan, Senior Vice President, Corporate Business Development (9)
|
38,891 | 2,592 | - | $ | 3.00 |
2/20/2023
|
- | - | - | - | |||||||||||||||||||||||
Andrew Chan, Senior Vice President, Corporate Business Development (10)
|
22,742 | 18,194 | - | $ | 5.61 |
5/16/2024
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (11)
|
162,917 | 92,083 | - | $ | 5.00 |
1/3/2024
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (12)
|
4,858 | 442 | - | $ | 7.23 |
3/5/2023
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (13)
|
5,000 | 10,000 | - | $ | 20.63 |
7/23/2021
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (14)
|
5,000 | 10,000 | - | $ | 20.63 |
8/14/2021
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (15)
|
32,600 | 65,200 | - | $ | 15.53 |
12/31/2021
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (16)
|
2,667 | 5,333 | - | $ | 15.53 |
12/31/2021
|
- | - | - | - | |||||||||||||||||||||||
Bizuo (Tony) Liu, Chief Financial Officer (17)
|
- | 30,000 | - | $ | 35.53 |
4/6/2025
|
- | - | - | - | |||||||||||||||||||||||
Terry A. Belmont (18)
|
4,000 | - | $ | 12.94 |
12/9/2024
|
- | - | - | - | ||||||||||||||||||||||||
3,000 | - | $ | 15.62 |
11/7/2024
|
- | - | - | - | |||||||||||||||||||||||||
David Bolocan (19)
|
7,000 | - | - | $ | 5.41 |
10/4/2023
|
- | - | - | - | |||||||||||||||||||||||
7,000 | - | - | $ | 18.60 |
10/4/2024
|
- | - | - | - | ||||||||||||||||||||||||
Jianping Dai (20)
|
883 | - | - | $ | 4.95 |
3/29/2023
|
- | - | - | - | |||||||||||||||||||||||
7,000 | - | - | $ | 5.40 |
9/26/2023
|
- | - | - | - | ||||||||||||||||||||||||
Healthcrest Ag
(21)
|
3,180 | 2,120 | - | $ | 5.50 |
12/9/2023
|
- | - | - | - | |||||||||||||||||||||||
Nadir Patel (22)
|
5,000 | - | - | $ | 5.00 |
1/3/2024
|
- | - | - | - | |||||||||||||||||||||||
2,000 | - | - | $ | 15.62 |
11/7/2024
|
- | - | - | - | ||||||||||||||||||||||||
- | 5,000 | - | $ | 13.79 |
1/3/2025
|
||||||||||||||||||||||||||||
Chun Kwok Alan Au (23)
|
4,000 | - | - | $ | 15.62 |
11/7/2024
|
- | - | - | - | |||||||||||||||||||||||
Guotong Xu (24)
|
2,000 | - | - | $ | 15.62 |
11/7/2024
|
- | - | - | - | |||||||||||||||||||||||
Richard L. Wang, Chief Operation Officer (25)
|
- | 30,000 | - | $ | 29.54 |
5/18/2025
|
- | - | - | - | |||||||||||||||||||||||
Richard L. Wang, Chief Operation Officer (26)
|
- | - | - | - |
N/A
|
20,000 | $ | 590,800 | - | - | |||||||||||||||||||||||
Yihong Yao, Chief Scientific Officer (27)
|
- | 25,000 | - | $ | 26.53 |
8/4/2025
|
- | - | - | - | |||||||||||||||||||||||
Yihong Yao, Chief Scientific Officer (28)
|
- | - | - | - |
N/A
|
25,000 | $ | 594,250 | - | - |
(1)
|
Represents an option to purchase up to 146,667 shares that were issued on 2/20/2013 with a monthly vesting schedule over a 36 month period, an exercise price of $3.00 and an expiration date of 2/20/2023.
|
(2)
|
Represents an option to purchase up to 33,667 shares that were issued on 2/11/2015 vesting 1/3 on 12/31/2015 and each anniversary, an exercise price of $15.53 and an expiration date of 12/31/2021.
|
(3)
|
Represents an option to purchase up to 56,667 shares that were issued on 2/20/2013 with a monthly vesting schedule over a 36 month period, an exercise price of $3.00 and an expiration date of 2/20/2023 and an additional option to purchase up to 33,333 shares issued on 2/20/2013 with full vesting on the second year anniversary of the award, an exercise price of $3.00 and an expiration date of 2/20/2023.
|
(4)
|
Represents an option to purchase up to 90,000 shares that were issued on 9/30/2013 with a monthly vesting schedule over a 36 month period, an exercise price of $5.40 and an expiration date of 9/30/2023, within which 20,000 shares has been exercised in 2015.
|
(5)
|
Represents an option to purchase up to 30,000 shares that were issued on 2/11/2015 vesting 1/3 on 7/23/2015 and each anniversary, an exercise price of $20.63 and an expiration date of 7/23/2021.
|
(6)
|
Represents an option to purchase up to 30,000 shares that were issued on 2/11/2015 vesting 1/3 on 8/14/2015 and each anniversary, an exercise price of $20.63 and an expiration date of 8/14/2021.
|
(7)
|
Represents an option to purchase up to 101,000 shares that were issued on 2/11/2015 vesting 1/3 on 12/31/2015 and each anniversary, an exercise price of $15.53 and an expiration date of 12/31/2021.
|
(8)
|
Represents an option to purchase up to 60,000 shares that were issued on 4/6/2015, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years, an exercise price of $35.53 and an expiration date of 4/6/2025.
|
(9)
|
Represents an option to purchase up to 46,667 shares that were issued on 2/20/2013 with a monthly vesting schedule over a 36-month period, an exercise price of $3.00 and an expiration date of 2/20/2023, within which 5,184 shares has been exercised in 2015.
|
(10)
|
Represents an option to purchase up to 47,000 shares that were issued on 5/16/2014 with a monthly vesting schedule over a 31-month period, an exercise price of $5.61 and an expiration date of 5/16/2024, within which 6,064 shares has been exercised in 2015.
|
(11)
|
Represents an option to purchase up to 255,000 shares that were issued on 1/3/2014 with a monthly vesting schedule over a 36-month period, an exercise price of $5 and an expiration date of 1/3/2024.
|
(12)
|
Represents an option to purchase up to 5,300 shares that were issued on 3/5/2013 with a monthly vesting schedule over a 36-month period, an exercise price of $7.23 and an expiration date of 3/5/2023.
|
(13)
|
Represents an option to purchase up to 15,000 shares that were issued on 2/11/2015 vesting 1/3 on 7/23/2015 and each anniversary, an exercise price of $20.63 and an expiration date of 7/23/2021.
|
(14)
|
Represents an option to purchase up to 15,000 shares that were issued on 2/11/2015 vesting 1/3 on 8/14/2015 and each anniversary, an exercise price of $20.63 and an expiration date of 8/14/2021.
|
(15)
|
Represents an option to purchase up to 97,800 shares that were issued on 2/11/2015 vesting 1/3 on 12/31/2015 and each anniversary, an exercise price of $15.53 and an expiration date of 12/31/2021.
|
(16)
|
Represents an option to purchase up to 8,000 shares that were issued on 2/11/2015 vesting 1/3 on 12/31/2015 and each anniversary, an exercise price of $15.53 and an expiration date of 12/31/2021.
|
(17)
|
Represents an option to purchase up to 30,000 shares that were issued on 4/6/2015, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years, an exercise price of $35.53 and an expiration date of 4/6/2025.
|
(18)
|
Represents an option to purchase up to 4,000 shares issued on 12/9/2014 with full vesting at the one year anniversary of the grant date, an exercise price of $12.94 and an expiration date of 12/9/2024 as well as an additional option to purchase up to 3,000 shares issued on 11/7/2014 with full vesting at the one year anniversary of the grant date, an exercise price of $15.62 and an expiration date of 11/7/2024.
|
(19)
|
Represents an option to purchase up to 7,000 shares that were issued on 10/4/2013, with full vesting at the one year anniversary of the grant date, an exercise price of $5.41 and an expiration date of 10/4/2023 and an additional option to purchase up to 7,000 shares that were issued on 10/4/2014, with full vesting at the one year anniversary of the grant date, an exercise price of $18.6 and an expiration date of 10/4/2024.
|
(20)
|
Represents an option to purchase up to 5,300 shares that were issued on 3/29/2013, with a monthly vesting schedule over a 36 month period, an exercise price of $4.95 and an expiration date of 3/29/2023. The award was amended on 9/26/2013 to 7,000 shares and 883 already vested shares on that date, with the amended shares fully vested at the one year anniversary of the grant date, an exercise price of $5.40 and an expiration date of 9/26/2023.
|
(21)
|
Represents an option to purchase up to 5,300 shares that were issued on 12/09/2013, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years, an exercise price of $5.50 and an expiration date of 12/09/2023.
|
(22)
|
Represents an option to purchase up to 5,000 shares that were issued on 1/3/2014, with full vesting at the one year anniversary of the grant date, an exercise price of $5 and an expiration date of 1/3/2024, an additional option to purchase up to 2,000 shares that were issued on 11/7/2014, with full vesting at the one year anniversary of the grant date, an exercise price of $15.62 and an expiration date of 11/7/2024, and an additional option to purchase up to 5,000 shares that were issued on 1/3/2015, with full vesting at the one year anniversary of the grant date, an exercise price of $13.79 and an expiration date of 1/3/2025.
|
(23)
|
Represents an option to purchase up to 4,000 shares that were issued on 11/7/2014, with full vesting at the one year anniversary of the grant date, an exercise price of $15.62 and an expiration date of 11/7/2024.
|
(24)
|
Represents an option to purchase up to 2,000 shares that were issued on 11/7/2014, with full vesting at the one year anniversary of the grant date, an exercise price of $15.62 and an expiration date of 11/7/2024.
|
(25)
|
Represents an option to purchase up to 30,000 shares that were issued on 5/18/2015, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years, an exercise price of $29.54 and an expiration date of 5/18/2025.
|
(26)
|
Represents a right to obtain restricted stock up to 20,000 shares that were issued on 5/18/2015, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years.
|
(27)
|
Represents an option to purchase up to 25,000 shares that were issued on 8/4/2015, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years, an exercise price of $26.53 and an expiration date of 8/4/2025.
|
(28)
|
Represents a right to obtain restricted stock up to 25,000 shares that were issued on 8/4/2015, with full vesting of 30%, 30% and 40% at each year anniversary of the grant date for 3 years.
|
Name
|
Option awards
|
Stock awards
|
||||||||||||||
Number of shares acquired on exercise
|
Value realized on exercise ($)
|
Number of shares acquired on vesting
|
Value realized on vesting ($)
|
|||||||||||||
Wen Tao (Steve) Liu, Director
|
33,333 | 1,126,989 | - | - | ||||||||||||
Wei (William) Cao, Director
|
20,000 | 269,800 | - | - | ||||||||||||
Andrew Chan, Senior Vice President, Corporate Business Development
|
44,581 | 765,384 | - | - | ||||||||||||
Terry A. Belmont, Independent Director, Chairman of the Board
|
4,000 | 126,600 | - | - | ||||||||||||
Yihong Yao, Chief Scientific Officer
|
- | - | 500 | 18,755 |
Name
|
Year
|
Salary
|
Bonus
|
Stock
|
Option
|
Non-Equity
|
Nonqualified
|
All Other
|
Total
|
|||||||||||||||||||||||||
($)
|
($)
|
Awards
|
Awards
|
Incentive Plan
|
Deferred
|
Compensation
|
($)
|
|||||||||||||||||||||||||||
($)
|
($)
|
Compensation
|
Compensation
|
($)
|
||||||||||||||||||||||||||||||
($)
|
Earnings
|
|||||||||||||||||||||||||||||||||
(note 1) | (note 2) |
($)
|
||||||||||||||||||||||||||||||||
Terry A. Belmont
|
2015
|
30,000 | - | - | - | - | - | - | 30,000 | |||||||||||||||||||||||||
David Bolocan
|
2015
|
30,000 | - | - | - | - | - | - | 30,000 | |||||||||||||||||||||||||
Wei (William) Cao
|
2015
|
18,337 | - | - | - | - | - | - | 18,337 | |||||||||||||||||||||||||
Gerardus A. Hoogland
|
2015
|
20,004 | - | - | - | - | - | - | 20,004 | |||||||||||||||||||||||||
Bizuo (Tony) Liu
|
2015
|
20,004 | - | - | - | - | - | - | 20,004 | |||||||||||||||||||||||||
Wen Tao (Steve) Liu
|
2015
|
20,004 | - | - | - | - | - | - | 20,004 | |||||||||||||||||||||||||
Nadir Patel
|
2015
|
30,000 | - | - | 60,617 | - | - | - | 90,617 | |||||||||||||||||||||||||
Chun Kwok Alan Au
|
2015
|
30,000 | - | - | - | - | - | 30,000 | ||||||||||||||||||||||||||
Guotong Xu
|
2015
|
32,500 | - | - | - | - | - | 32,500 |
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
|
Name and Address of Beneficial Owner
|
Shares of Common Stock
|
Percent
|
||||||
Beneficially Owned
|
of Class
|
|||||||
Named Executive Officers and Directors
|
||||||||
Wen Tao (Steve) Liu (1)
|
370,965 | 2.9 | % | |||||
Director
|
||||||||
Wei (William) Cao (2)
|
384,508 | 3 | % | |||||
Director
|
||||||||
Bizuo (Tony) Liu (3)
|
350,818 | 2.8 | % | |||||
Director, Chief Executive Officer, Chief Financial Officer and Secretary
|
||||||||
Andrew Chan (4)
|
210,411 | 1.7 | % | |||||
Senior Vice President, Corporate Business Development
|
||||||||
Yihong Yao
|
500 | * | ||||||
Chief Scientific Officer (5)
|
||||||||
Gerardus A. Hoogland (6)
|
3,180 | * | ||||||
Non-independent Director
|
||||||||
David Bolocan (7)
|
24,000 | * | ||||||
Independent Director
|
||||||||
Terry A. Belmont (8)
|
7,000 | * | ||||||
Independent Director, Chairman of the Board
|
||||||||
Nadir Patel (9)
|
12,000 | * | ||||||
Independent Director
|
||||||||
Chun Kwok Alan Au (10)
|
4,000 | * | ||||||
Independent Director
|
||||||||
Guotong Xu (11)
|
2,000 | * | ||||||
Independent Director
|
||||||||
All Officers and Directors as a Group
|
1,369,382 | 10.8 | % | |||||
5% or more Stockholders
|
||||||||
Mission Right Limited (12)
|
1,036,040 | 8.6 | % | |||||
Leung Pak To (13)
|
711,220 | 5.9 | % | |||||
Cellular Immunity Tech Ltd. (14)
|
753,522 | 6.3 | % | |||||
ING Asia Private Bank LTD
|
629,229 | 5.3 | % |
(1)
|
Total shares owned by Wen Tao (Steve) Liu includes (i) 153,418 shares of common stock; (ii)146,667 options issued under 2011 Plan vested/to be vested within 60 days as of February 29, 2016; (iii) 11,222 options issued under 2014 Plan vested/to be vested within 60 days as of February 29, 2016.
|
(2)
|
Wei (William) Cao shares voting and dispositive power over the shares held by W & J Development Ltd. with his spouse. Total shares owned by Mr. Cao includes (i) 174,472 shares directly by him; (ii) 25,145 shares held by W & J Development Ltd.; (iii) 90,000 options issued under the 2011 Plan vested/to be vested within 60 days as of February 29, 2016; (iv) 50,000 options issued under the 2013 Plan vested/to be vested within 60 days as of February 29, 2016, (v) 44,891 options issued under the 2014 Plan vested/to be vested within 60 days as of February 29, 2016.
|
(3)
|
Total shares owned by Bizuo (Tony) Liu includes (i) 100,000 shares of common stock; (ii)5,300 options issued under 2011 Plan vested/to be vested within 60 days as of February 29, 2016; (iii)191,251 options issued under 2013 Plan vested/to be vested within 60 days as of February 29, 2016; (iv) 54,267 options issued under 2013 Plan vested/to be vested within 60 days as of February 29, 2016.
|
(4)
|
Total shares owned by Andrew Chan includes (i) 145,757 shares of common stock; (ii)38,880 options issued under 2011 Plan vested/to be vested within 60 days as of February 29, 2016; (iii) 25,774 options issued under 2013 Plan vested/to be vested within 60 days as of February 29, 2016.
|
(5)
|
Total shares owned by Yihong Yao includes 500 shares of common stock.
|
(6)
|
Total shares owned by Gerardus Hoogland includes 3,180 options issued under 2013 Plan vested as of February 29, 2016. Mr. Hoogland was nominated to the Board pursuant to the terms of an advisory agreement with Healthcrest AG dated August 23, 2013. Mr. Hoogland is chief executive officer of Healthcrest. Healthcrest is 100% owned by Jacesa Investments Ltd, which is 100% owned by Rosetrust Nominees Ltd. Howard Rosen controls Rosetrust Nominees Ltd. In addition to the 3,180 vested options held directly by Mr. Hoogland, Healthcrest and its affiliates beneficially own an aggregate of 393,932 shares of CBMG common stock, of which 119,000 shares are held in Healthcrest’s name. Except for the options issued as compensation for services as a director of CBMG, Mr. Hoogland disclaims beneficial ownership of all of the CBMG shares attributed to Healthcrest and its affiliates.
|
(7)
|
Total shares owned by David Bolocan includes (i) 10,000 shares of common stock; (ii) 14,000 options issued under 2013 Plan vested as of February 29, 2016.
|
(8)
|
Total shares owned by Terry A. Belmont includes 7,000 options issued under 2013 Plan vested as of February 29, 2016.
|
(9)
|
Total shares owned by Nadir Patel includes 12,000 options issued under 2013 Plan vested as of February 29, 2016.
|
(10)
|
Total shares owned by Chun Kwok Alan Au includes 4,000 options issued under 2013 Plan vested as of February 29, 2016.
|
(11)
|
Total shares owned by Guotong Xu includes 2,000 options issued under 2013 Plan vested as of February 29, 2016.
|
(12)
|
Mission Right Limited is 50% owned by Yusen Holdings Limited and 50% by Zeacome Investment Limited. Chan Boon Ho Peter controls Yusen Holdings. Zeacome Investment Limited is owned by Perfect Touch Technology Inc., which is owned by CST Mining Group Limited. CST Mining Group Limited is a public company listed on the Hong Kong Stock Exchange under the ticker code “985.” Accordingly, Chan Boon Ho Peter and CST Mining Group Limited beneficially own the shares held by Mission Right Limited.
|
(13)
|
711,220 shares beneficially owned by Mr. Leung are held by Full Moon Resources Limited, an entity which Mr. Leung controls.
|
(14)
|
Cellular
Immunity Tech Ltd. is beneficially owned by 7 companies. Agreen – Tech Ltd. accounts for 45% of its interest and is owned by Dr. Kou Zhongxun, who is the employee of the company. Pureland Evergreen Ltd. accounts for 26% of the interest and is owned by Xu Chengbin, who is the employee of the company. Agreen Cellular Immunotherapy Ltd. accounts for 10% of the interest and is owned by Zhang Wei. Cellular Immunotherapy Ltd. is owned by Li Yaohua, who is the employee of the company. Biotechnology – Tech Ltd. accounts for 5% of the interest and is owned by Wu Pengfei, who is the employee of the company. Heaven Mind Ltd. accounts for 5% of the interest and is owned by Wu Shanshan, who is the employee of the company. Index Hong Kong Limited accounts for 4% of the interest and is owned by Zhang Dong.
|
ITEM 13.
CERTAIN RELATIONSHIPS, RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
|
Year ended December 31, 2015
|
Year ended December 31, 2014
|
Year ended December 31, 2013
|
||||||||||
Audit and review fees
|
||||||||||||
BDO USA, LLP
|
137,801 | 217,256 | 200,000 | |||||||||
BDO Shanghai, LLP
|
148,894 | 118,049 | 43,578 | |||||||||
Dahua CPA Co., Ltd.
|
- | 3,257 | 23,726 | |||||||||
Taravan, Askelson & Company
|
- | - | 107,293 | |||||||||
Shanghai Ying Ming De CPA SGP
|
1,514 | - | - | |||||||||
Wuxi Zhong Xing CPA Co., Ltd.
|
757 | - | - | |||||||||
C.K.Lam & Co.
|
1,721 | - | - | |||||||||
290,687 | 338,562 | 374,597 | ||||||||||
Other assurance and tax fees
|
||||||||||||
Shanghai Ying Ming De CPA SGP
|
3,785 | - | - | |||||||||
Wuxi Zhong Xing CPA Co., Ltd.
|
1,666 | - | - | |||||||||
Total of audit related and tax fees
|
5,451 | - | - | |||||||||
Overall total of audit, review and assurance fees
|
$ | 296,138 | $ | 338,562 | $ | 374,597 |
ITEM 15.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
|
Exhibit Number
|
Description
|
|
2.1
|
Plan of reorganization and exchange agreement (1)
|
|
2.2
|
Agreement and Plan of Merger, dated November 13, 2012 (17)
|
|
2.3
|
Amendment No. 1 to Agreement and Plan of Merger, dated January 15, 2013 (18)
|
|
2.4
|
Amendment No. 2 to Agreement and Plan of Merger, dated January 31, 2013 (19)
|
|
2.5
|
Amendment No. 3 to Agreement and Plan of Merger, dated February 5, 2013 (20)
|
|
3.1
|
Articles of Incorporation of Cellular Biomedicine Group, Inc., filed herewith.
|
|
3.2
|
Corporate bylaws for Cellular Biomedicine Group, Inc., filed herewith.
|
|
4.1
|
Form of lock-up agreement (1)
|
|
4.2
|
2007 Stock Incentive Plan, dated June 14, 2007 (3)
|
|
4.3
|
2008 Employees and Consultants Stock Option Plan, dated August 20, 2008 (8)
|
|
4.4
|
2009 Stock Option Plan (10)
|
|
4.5
|
2011 Incentive Stock Option Plan (22)
|
|
4.6
|
Amended and Restated 2011 Incentive Stock Option Plan (23)
|
|
4.7
|
2013 Stock Incentive Plan (28)
|
|
4.8
|
2014 Stock Incentive Plan (29)
|
|
10.1
|
Consulting Employment Agreement between EastBridge Investment Group Corporation and Keith Wong dated June 1, 2005 (1)
|
|
10.2
|
Consulting Employment Agreement between EastBridge Investment Group Corporation and Norm Klein dated June 1, 2005 (1)
|
|
10.3
|
Listing Agreement signed with Amonics Limited, dated November 23, 2006 (English translation) (2)
|
|
10.4
|
Listing Agreement signed with Tianjin Hui Hong Heavy Steel Construction Co., Ltd, dated December 3, 2006 (English translation) (2)
|
|
10.5
|
Listing Agreement signed with NingGuo Shunchang Machinery Co., Ltd., dated January 6, 2007 (English translation) (2)
|
|
10.6
|
Listing Agreement with Hefe Ginko Real Estate Company, Ltd., dated July 24, 2007 (English translation) (4)
|
|
10.7
|
Share Exchange Agreement with AREM Wine Pty, Ltd., dated September 21, 2007 (5)
|
|
10.8
|
Listing and Consultant Agreement with AREM Wine Pty, Ltd., dated September 27, 2007 (6)
|
|
10.9
|
Listing Agreement with Beijing Zhong Zhe Huang Holding Company, Ltd., dated October 4, 2007 (English translation) (7)
|
|
10.10
|
Listing Agreement with Qinhuangdao Huangwei Pharmaceutical Company Limited, dated December 29, 2007 (English translation) (12)
|
|
10.11
|
US Listing Agreement with Anhui Wenda Educational & Investment Management Corporation, dated April 12, 2008 (English translation) (12)
|
|
10.12
|
Stock Purchase Agreement with Ji-Bo Pipes & Valves Company, dated September 21, 2008 (9)
|
|
10.13
|
Stock Purchase Agreement with Aoxing Corporation, dated September 21, 2008 (9)
|
|
10.14
|
US Listing Agreement with Foshan Jinkuizi Technology Limited Company, dated September 22, 2008 (English translation) (12)
|
|
10.15
|
Letter Agreement with Alpha Green Energy Limited, dated February 18, 2009 (12)
|
|
10.16
|
Listing Agreement with AREM Pacific Corporation, dated April 30, 2009 (12)
|
|
10.17
|
Change in Terms Agreement between EastBridge Investment Group Corporation and Goldwater Bank, N.A. dated May 6, 2009 (12)
|
Exhibit Number
|
Description
|
|
10.18
|
Listing Agreement with SuZhou KaiDa Road Pavement Construction Company Limited, dated November 3, 2009 (English translation) (12)
|
|
10.19
|
Listing Agreement with Long Whole Enterprises, Ltd., dated November 28, 2009 (English translation) (12)
|
|
10.20
|
Listing Agreement with Beijing Tsingda Century Education Investment and Consultancy Limited, dated December 24, 2009 (English translation) (12)
|
|
10.21
|
Listing Agreement with StrayArrow International Limited, dated April 11, 2010 (English translation) (13)
|
|
10.22
|
Listing Agreement with Hangzhou Dwarf Technology Ltd., dated September 26, 2010 (English translation) (14)
|
|
10.23
|
Bridge Capital Raise Agreement with FIZZA, LLC, dated December 1, 2010 (confidential treatment requested for redacted portions) (15)
|
|
10.24
|
Stock Purchase Agreement with An Lingyan, dated December 14, 2012 (1)
|
|
10.25
|
Form of Listing Agreement (16)
|
|
10.26
|
Tsingda Stock Purchase Agreement dated as of December 17, 2012 (16)
|
|
10.27
|
Employment Agreement with Wen Tao (Steve) Liu, dated February 6, 2013(30)
|
|
10.8
|
Employment Agreement with Wei (William) Cao, dated February 6, 2013(30)
|
|
10.29
|
Employment Agreement with Andrew Chan, February 6, 2013(30)
|
|
10.30
|
Form of Director Agreement(31)
|
|
10.31
|
Amendment to Employment Agreement with Wen Tao (Steve) Liu, dated August 20, 2013(30)
|
|
10.32
|
Amendment to Employment Agreement with Wei (William) Cao, dated August 20, 2013(30)
|
|
10.33
|
Amendment to Employment Agreement with Andrew Chan, dated August 20, 2013(30)
|
|
10.34
|
Advisory Services Agreement, dated August 23, 2013, by and between Cellular Biomedicine Group Inc. and HealthCrest AG(30)
|
|
10.35
|
Purchase Agreement, dated September 10, 2013, by and between Cellular Biomedicine Group (Shanghai) Ltd. and Fisher Scientific Worldwide (Shanghai) Co., Ltd. (30)
|
|
10.36
|
Technical Service Contract, dated September 22, 2013, by and between Cellular Biomedicine Group (Shanghai) Ltd. and National Engineering Research Center of Tissue Engineering. (30)
|
|
10.37
|
Clinical Trial Agreement, dated November 6, 2013, by and between Cellular Biomedicine Group (Shanghai) Ltd. and Renji Hospital(30)
|
|
10.38
|
Clinical Trial Agreement, dated December 20, 2013, by and between Cellular Biomedicine Group (Shanghai) Ltd. and China Armed Police General Hospital(30)
|
|
10.39
|
Consulting Agreement with Wei (William) Cao, dated February 7, 2016*
|
|
10.40
|
Form of Subscription Agreement (24)
|
|
10.41
|
Employment Agreement with Bizuo (Tony) Liu, dated January 3, 2014 (25)
|
|
10. 42
|
Framework Agreement by and among the Company, Agreen Biotech Co. Ltd. and its Shareholders, dated August 02, 2014 (26)
|
|
10.43
|
Technology Transfer Agreement by and between the Company and the General Hospital of the Chinese People’s Liberation Army, dated February 4, 2015*
|
|
10.44
|
Asset Purchase Agreement, dated June 8, 2015, by and among the Company, Blackbird BioFinance, LLC, Scott Antonia and Sam Shrivastava (27)
|
|
10.45 |
Patent Transfer Agreement, dated November 16, 2015, by and between CBMG Shanghai and China Pharmaceutical University*
|
|
10.46 |
Clinical Trial Agreement, dated December 15, 2015, by and between CBMG Shanghai and Renji Hospital*
|
|
14.1
|
Code of Ethics for EastBridge Investment Group Corporation (1)
|
|
21
|
Subsidiaries of the Company*
|
|
Consent of BDO USA LLP*
|
||
Consent of BDO China Shu Lun Pan Certified Public Accountants LLP *
|
||
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Executive Officer and Chief Financial Officer*
|
||
Certifications Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, furnished herewith.
|
||
101.INS*
|
XBRL Instance Document
|
|
101.SCH* | XBRL Taxonomy Extension Schema Document | |
101.CAL* | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB* | XBRL Taxonomy Extension Label Linkbase Document | |
101.PRE* | XBRL Taxonomy Extension Presentation Linkbase Document |
1.
|
Incorporated by reference filed with the Registration Statement on Form 10-SB filed with the Securities and Exchange Commission on October 30, 2006 (File No. 000-52282)
|
2.
|
Incorporated by reference filed with the Registration Statement on Form 10-SB/A filed with the Securities and Exchange Commission on February 27, 2007 (File No. 000-52282)
|
3.
|
Incorporated by reference filed with the Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 19, 2007 (File No. 333-143878)
|
4.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on July 20, 2007 (File No. 000-52282)
|
5.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on September 25, 2007 (File No. 000-52282)
|
6.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on October 1, 2007 (File No. 000-52282)
|
7.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on October 9, 2007 (File No. 000-52282)
|
8.
|
Incorporated by reference filed with the Registration Statement on Form S-8 filed with the Securities and Exchange Commission on August 22, 2008 (File No. 333-153129)
|
9.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on October 22, 2008 (File No. 000-52282)
|
10.
|
Incorporated by reference filed with the Registration Statement on Form S-8 filed with the Securities and Exchange Commission on April 15, 2009 (File No. 333-158583)
|
11.
|
Incorporated by reference filed with the Form 8-K/A filed with the Securities and Exchange Commission on December 12, 2013 (File No. 000-52282)
|
12.
|
Incorporated by reference filed with the Form 10-K filed with the Securities and Exchange Commission on April 15, 2010 (File No. 000-52282)
|
13.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on July 14, 2010 (File No. 000-52282)
|
14.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on November 12, 2010 (File No. 000-52282
|
15.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on December 7, 2010 (File No. 000-52282)
|
16.
|
Incorporated by reference filed with the Form 10-K filed with the Securities and Exchange Commission on June 18, 2013 (File No. 000-52282)
|
17.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on November 20, 2012 (File No. 000-52282)
|
18.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on January 22, 2013 (File No. 000-52282)
|
19.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on February 4, 2013 (File No. 000-52282)
|
20.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on February 12, 2013 (File No. 000-52282)
|
21.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on January 3, 2012 (File No. 000-52282)
|
22.
|
Incorporated by reference filed with the Registration Statement on Form S-8 filed with the Securities and Exchange Commission on March 7, 2012 (File No. 333-179974)
|
23.
|
Incorporated by reference filed with the Form 10-K filed with the Securities and Exchange Commission on April 4, 2013 (File No. 000-52282)
|
24.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on December 16, 2013 (File No. 000-52282)
|
25.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on January 3, 2014 (File No. 000-52282)
|
26.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on October 2, 2014 (File No. 001-36498)
|
27.
|
Incorporated by reference filed with the Form 8-K filed with the Securities and Exchange Commission on July 2, 2015 (File No. 001-36498)
|
28.
|
Incorporated by reference filed with Schedule 14A filed with the Securities and Exchange Commission on November 21, 2013 (File No. 000-52282)
|
29.
|
Incorporated by reference filed with Schedule 14A filed with the Securities and Exchange Commission on September 23, 2014 (File No. 001-36498)
|
30
|
Incorporated by reference filed with the Form 10-K filed with the Securities and Exchange Commission on April 15, 2014 (File No. 000-52282).
|
31
|
Incorporated by reference filed with the Form 10-K filed with the Securities and Exchange Commission on March 31, 2015 (File No. 001-36498).
|
Registrant
|
Cellular Biomedicine Group, Inc.
|
||
Date: March 11, 2016
|
By:
|
/s/ Bizou (Tony) Liu | |
Bizuo (Tony) Liu
|
|||
Chief Executive Officer and Chief Financial Officer
(principal executive officer and financial and accounting officer)
|
|||
Signature
|
Title
|
Date
|
||
/s/ Terry A. Belmont |
Chairman of the Board of Directors
|
March 11, 2016
|
||
Terry A. Belmont
|
||||
/s/ Wei (William) Cao |
Director
|
March 11, 2016
|
||
Wei (William) Cao
|
||||
/s/ Bizuo (Tony) Liu |
Chief Executive Officer, Chief Financial Officer and Secretary
|
March 11, 2016
|
||
Bizuo (Tony) Liu
|
(principal executive officer and financial and accounting officer)
|
|||
/s/ Wen Tao (Steve) Liu |
Director
|
March 11, 2016
|
||
Wen Tao (Steve) Liu
|
||||
/s/ David Bolocan |
Director
|
March 11, 2016
|
||
David Bolocan
|
||||
/s/ Gerardus A. Hoogland |
Director
|
March 11, 2016
|
||
Gerardus A. Hoogland
|
||||
/s/ Nadir Patel |
Director
|
March 11, 2016
|
||
Nadir Patel
|
||||
/s/ Chun Kwok Alan Au |
Director
|
March 11, 2016
|
||
Chun Kwok Alan Au
|
||||
/s/ Guotong Xu |
Director
|
March 11, 2016
|
||
Guotong Xu
|
Page
|
||||
REPORTS OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMS
|
F-2
|
|||
CONSOLIDATED FINANCIAL STATEMENTS:
|
||||
Consolidated Balance Sheets at December 31, 2015 and 2014
|
F-5
|
|||
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2015, 2014 and 2013
|
F-6
|
|||
Consolidated Statements of Stockholders' Equity for the years ended December 31, 2015, 2014 and 2013
|
F-7
|
|||
Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013
|
F-8
|
|||
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
F-9
|
December 31,
|
December 31,
|
|||||||
2015
|
2014
|
|||||||
Assets
|
||||||||
Cash and cash equivalents
|
$ | 14,884,597 | $ | 14,770,584 | ||||
Accounts receivable
|
630,332 | 141,029 | ||||||
Other receivables
|
271,344 | 135,957 | ||||||
Inventory
|
390,886 | 372,249 | ||||||
Prepaid expenses
|
367,050 | 565,299 | ||||||
Taxes recoverable
|
150,082 | - | ||||||
Other current assets
|
- | 110,347 | ||||||
Total current assets
|
16,694,291 | 16,095,465 | ||||||
Investments
|
5,379,407 | 6,886,033 | ||||||
Property, plant and equipment, net
|
2,768,900 | 1,280,410 | ||||||
Goodwill
|
7,678,789 | 7,678,789 | ||||||
Intangibles, net
|
15,949,100 | 11,156,676 | ||||||
Long-term prepaid expenses and other assets
|
989,935 | 587,729 | ||||||
Total assets (1)
|
$ | 49,460,422 | $ | 43,685,102 | ||||
Liabilities and Stockholders' Equity
|
||||||||
Liabilities:
|
||||||||
Accounts payable
|
$ | 260,886 | $ | 426,917 | ||||
Accrued expenses
|
845,087 | 2,074,384 | ||||||
Taxes payable
|
- | 814,288 | ||||||
Advances payable to related party
|
- | 36,254 | ||||||
Other current liabilities
|
1,913,284 | 724,479 | ||||||
Total current liabilities
|
3,019,257 | 4,076,322 | ||||||
Other non-current liabilities
|
76,229 | 452,689 | ||||||
Total liabilities (1)
|
3,095,486 | 4,529,011 | ||||||
Commitments and Contingencies (note 16)
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, par value $.001, 50,000,000 shares
|
||||||||
authorized; none issued and outstanding as of
|
||||||||
December 31, 2015 and 2014, respectively
|
- | - | ||||||
Common stock, par value $.001, 300,000,000 shares authorized;
|
||||||||
11,711,645 and 10,990,335 issued and outstanding
|
||||||||
as of December 31, 2015 and 2014, respectively
|
11,711 | 10,990 | ||||||
Additional paid in capital
|
103,807,651 | 75,467,316 | ||||||
Accumulated deficit
|
(57,338,311 | ) | (37,890,590 | ) | ||||
Accumulated other comprehensive income (loss)
|
(116,115 | ) | 1,568,375 | |||||
Total stockholders' equity
|
46,364,936 | 39,156,091 | ||||||
Total liabilities and stockholders' equity
|
$ | 49,460,422 | $ | 43,685,102 |
(1)
|
The Company’s consolidated assets as of December 31, 2015 and 2014 included $6,115,073 and $5,508,459, respectively, of assets of variable interest entities, or VIEs, that can only be used to settle obligations of the VIEs. Each of the following amounts represent the balances as of December 31, 2015 and 2014, respectively. These assets include cash and cash equivalents of $1,821,883 and $3,496,678; accounts receivable of $337,345 and $141,029; other receivables of $136,621 and $127,280; inventory of $180,973 and $215,152; prepaid expenses of $250,123 and $193,613; other current assets of $ nil and $109,777; property, plant and equipment, net, of $1,145,924 and $1,055,648; intangibles of $1,892,551 and $42,779; and long-term prepaid expenses and other assets of $349,653 and $126,503. The Company’s consolidated liabilities as of December 31, 2015 and 2014 included $1,478,160 and $1,434,826, respectively, of liabilities of the VIEs whose creditors have no recourse to the Company. These liabilities include accounts payable of $38,004 and $10,572; other payables of $914,817 and $714,309; payroll accrual of $464,510 and $273,599; and other non-current liabilities of $60,829 and $436,346. See further description in Note 6, Variable Interest Entities.
|
For the Year Ended
December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
(Note 23)
|
(Note 23)
|
|||||||||||
Net sales and revenue
|
$ | 2,505,423 | $ | 564,377 | $ | 204,914 | ||||||
Operating expenses:
|
||||||||||||
Cost of sales
|
1,880,331 | 242,215 | 296,212 | |||||||||
General and administrative
|
13,068,255 | 7,875,413 | 9,162,172 | |||||||||
Selling and marketing
|
709,151 | 314,894 | 58,275 | |||||||||
Research and development
|
7,573,228 | 3,146,499 | 2,041,872 | |||||||||
Impairment of investments
|
123,428 | 1,427,840 | - | |||||||||
Total operating expenses
|
23,354,393 | 13,006,861 | 11,558,531 | |||||||||
Operating loss
|
(20,848,970 | ) | (12,442,484 | ) | (11,353,617 | ) | ||||||
Other income (expense):
|
||||||||||||
Interest income
|
42,220 | 15,043 | 1,294 | |||||||||
Other income (expense)
|
630,428 | 71,982 | (6,196 | ) | ||||||||
Total other income (expense)
|
672,648 | 87,025 | (4,902 | ) | ||||||||
Loss from continuing operations before taxes
|
(20,176,322 | ) | (12,355,459 | ) | (11,358,519 | ) | ||||||
Income taxes (expense) credit
|
728,601 | - | - | |||||||||
Loss from continuing operations
|
(19,447,721 | ) | (12,355,459 | ) | (11,358,519 | ) | ||||||
Loss on discontinued operations, net of taxes
|
- | (3,119,152 | ) | (2,438,514 | ) | |||||||
Net loss
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (13,797,033 | ) | |||
Other comprehensive income (loss):
|
||||||||||||
Cumulative translation adjustment
|
(307,950 | ) | 15,254 | 78,650 | ||||||||
Unrecognized gain (loss) on investments
|
(1,376,540 | ) | 1,611,045 | (198,200 | ) | |||||||
Total other comprehensive income (loss):
|
(1,684,490 | ) | 1,626,299 | (119,550 | ) | |||||||
Comprehensive loss
|
$ | (21,132,211 | ) | $ | (13,848,312 | ) | $ | (13,916,583 | ) | |||
Loss per share for continuing operations:
|
||||||||||||
Basic
|
$ | (1.70 | ) | $ | (1.43 | ) | $ | (1.96 | ) | |||
Diluted
|
$ | (1.70 | ) | $ | (1.43 | ) | $ | (1.96 | ) | |||
Loss per share for discontinued operations:
|
||||||||||||
Basic
|
$ | - | $ | (0.36 | ) | $ | (0.42 | ) | ||||
Diluted
|
$ | - | $ | (0.36 | ) | $ | (0.42 | ) | ||||
Net loss per share :
|
||||||||||||
Basic
|
$ | (1.70 | ) | $ | (1.79 | ) | $ | (2.38 | ) | |||
Diluted
|
$ | (1.70 | ) | $ | (1.79 | ) | $ | (2.38 | ) | |||
Weighted average common shares outstanding:
|
||||||||||||
Basic
|
11,472,306 | 8,627,094 | 5,792,888 | |||||||||
Diluted
|
11,472,306 | 8,627,094 | 5,792,888 |
Accumulated Other
|
||||||||||||||||||||||||||||||||
Common Stock
|
Preferred Stock
|
Additional
|
Accumulated
|
Comprehensive
|
||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Paid in Capital
|
Deficit
|
Income (Loss)
|
Total
|
|||||||||||||||||||||||||
Balance at December 31, 2012
|
3,710,560 | $ | 3,711 | - | $ | - | $ | 14,710,002 | $ | (8,618,946 | ) | $ | 61,626 | $ | 6,156,393 | |||||||||||||||||
Common stock issued with Private Placement Memorandum ("PPM")
|
1,434,778 | 1,435 | - | - | 8,990,956 | - | - | 8,992,391 | ||||||||||||||||||||||||
Common stock issued for services
|
231,384 | 231 | - | - | 1,156,868 | - | - | 1,157,099 | ||||||||||||||||||||||||
Stock based compensation
|
93,416 | 93 | - | - | 736,559 | - | - | 736,652 | ||||||||||||||||||||||||
Restricted stock grants
|
- | - | - | - | 255,993 | - | - | 255,993 | ||||||||||||||||||||||||
Accrual of stock options
|
- | - | - | - | 536,652 | - | - | 536,652 | ||||||||||||||||||||||||
Reverse merger with EastBridge
|
1,570,299 | 1,571 | - | - | 9,780,223 | - | - | 9,781,794 | ||||||||||||||||||||||||
Contigent stock issuance
|
342,360 | 342 | - | - | 1,694,340 | - | - | 1,694,682 | ||||||||||||||||||||||||
Unrecognized loss on investments
|
- | - | - | - | - | - | (198,200 | ) | (198,200 | ) | ||||||||||||||||||||||
Foreign currency translation
|
- | - | - | - | - | - | 78,650 | 78,650 | ||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | (13,797,033 | ) | - | (13,797,033 | ) | ||||||||||||||||||||||
Balance at December 31, 2013
|
7,382,797 | $ | 7,383 | - | $ | - | $ | 37,861,593 | $ | (22,415,979 | ) | $ | (57,924 | ) | $ | 15,395,073 | ||||||||||||||||
Common stock issued with PPM
|
1,686,566 | 1,686 | - | - | 11,120,270 | - | - | 11,121,956 | ||||||||||||||||||||||||
Common stock issued for services
|
43,760 | 44 | - | - | 578,937 | - | - | 578,981 | ||||||||||||||||||||||||
Stock based compensation
|
13,413 | 13 | - | - | 207,188 | - | - | 207,201 | ||||||||||||||||||||||||
Restricted stock grants
|
13,862 | 14 | - | - | 106,378 | - | - | 106,392 | ||||||||||||||||||||||||
Accrual of stock options
|
- | - | - | - | 1,636,311 | - | - | 1,636,311 | ||||||||||||||||||||||||
Exercise of stock options
|
3,650 | 4 | - | - | 19,383 | - | - | 19,387 | ||||||||||||||||||||||||
Exercise of warrant issued in PPM
|
1,017,765 | 1,018 | - | - | 7,998,978 | - | - | 7,999,996 | ||||||||||||||||||||||||
Common stock issued for acquisition
|
828,522 | 828 | - | - | 15,938,278 | - | - | 15,939,106 | ||||||||||||||||||||||||
Unrecognized gain on investments
|
- | - | - | - | - | - | 1,611,045 | 1,611,045 | ||||||||||||||||||||||||
Foreign currency translation
|
- | - | - | - | - | - | 15,254 | 15,254 | ||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | (15,474,611 | ) | - | (15,474,611 | ) | ||||||||||||||||||||||
Balance at December 31, 2014
|
10,990,335 | 10,990 | - | - | 75,467,316 | (37,890,590 | ) | 1,568,375 | 39,156,091 | |||||||||||||||||||||||
Common stock issued with PPM
|
515,786 | 516 | - | - | 18,584,338 | - | - | 18,584,854 | ||||||||||||||||||||||||
Common stock issued for
acquisition of intangible assets
|
46,867 | 47 | - | - | 1,481,415 | 1,481,462 | ||||||||||||||||||||||||||
Restricted stock grants
|
6,253 | 6 | - | - | 410,314 | - | - | 410,320 | ||||||||||||||||||||||||
Accrual of stock options
|
- | - | - | - | 7,182,117 | - | - | 7,182,117 | ||||||||||||||||||||||||
Exercise of stock options
|
152,404 | 152 | - | - | 682,151 | - | - | 682,303 | ||||||||||||||||||||||||
Unrecognized loss on investments
|
- | - | - | - | - | - | (1,376,540 | ) | (1,376,540 | ) | ||||||||||||||||||||||
Foreign currency translation
|
- | - | - | - | - | - | (307,950 | ) | (307,950 | ) | ||||||||||||||||||||||
Net loss
|
- | - | - | - | - | (19,447,721 | ) | - | (19,447,721 | ) | ||||||||||||||||||||||
Balance at December 31, 2015
|
11,711,645 | $ | 11,711 | - | $ | - | $ | 103,807,651 | $ | (57,338,311 | ) | $ | (116,115 | ) | $ | 46,364,936 |
For the Year Ended
|
||||||||||||
December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net loss
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (13,797,033 | ) | |||
Adjustments to reconcile net loss to net cash
|
||||||||||||
used in operating activities:
|
||||||||||||
Depreciation and amortization
|
2,094,644 | 1,190,505 | 841,235 | |||||||||
Loss on disposal of assets
|
1,444 | 257,672 | - | |||||||||
Stock based compensation expense
|
7,592,438 | 2,528,885 | 4,381,077 | |||||||||
Other than temporary impairment on investments
|
123,428 | 1,427,840 | - | |||||||||
Realized losses from sale of investments
|
5,178 | 5,913 | 138,909 | |||||||||
Value of stock received for services
|
- | (1,610,000 | ) | (3,500,000 | ) | |||||||
Impairment of goodwill
|
- | 3,299,566 | 4,258,967 | |||||||||
Inventory provision
|
123,848 | - | - | |||||||||
Decrease in fair value of accrued expenses for the acquisition of intangible assets
|
(345,882 | ) | - | - | ||||||||
Third party services received in exchange for disposition of investment stock
|
- | - | 83,334 | |||||||||
Deferred tax
|
- | - | (76,544 | ) | ||||||||
Changes in operating assets and liabilities:
|
||||||||||||
Accounts receivable
|
(497,937 | ) | 20,645 | 10,102 | ||||||||
Other receivables
|
(143,711 | ) | (25,638 | ) | 50,160 | |||||||
Inventory
|
(142,486 | ) | (78,310 | ) | (81,878 | ) | ||||||
Prepaid expenses
|
181,679 | (494,057 | ) | (38,793 | ) | |||||||
Taxes recoverable
|
(150,082 | ) | - | - | ||||||||
Other current assets
|
110,347 | 24,314 | (84,661 | ) | ||||||||
Investments
|
- | 7,150 | - | |||||||||
Long-term prepaid expenses and other assets
|
(384,432 | ) | (504,678 | ) | 134,229 | |||||||
Accounts payable
|
(166,032 | ) | 165,517 | 40,862 | ||||||||
Accrued expenses
|
396,557 | 409,109 | (739,839 | ) | ||||||||
Advance payable to related party
|
(30,216 | ) | - | - | ||||||||
Other current liabilities
|
113,919 | (694,131 | ) | 186,464 | ||||||||
Taxes payable
|
(814,288 | ) | (176,583 | ) | (10,121 | ) | ||||||
Other non-current liabilities
|
(371,793 | ) | - | (251,834 | ) | |||||||
Net cash used in operating activities
|
(11,751,098 | ) | (9,720,892 | ) | (8,455,364 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Acquisition of business, net of cash acquired
|
(1,568,627 | ) | (1,485,548 | ) | - | |||||||
Proceed from sale of investments, net of transaction costs
|
1,480 | - | - | |||||||||
Purchases of intangible assets
|
(4,260,420 | ) | (8,989 | ) | (5,828 | ) | ||||||
Purchases of property, plant and equipment
|
(1,874,538 | ) | (311,625 | ) | (147,211 | ) | ||||||
Net cash used in investing activities
|
(7,702,105 | ) | (1,806,162 | ) | (153,039 | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Net proceeds from the issuance of common stock
|
18,964,849 | 19,121,956 | 11,561,386 | |||||||||
Proceeds from exercise of stock options
|
682,303 | 19,383 | - | |||||||||
Advance from affiliates
|
- | - | 36,614 | |||||||||
Repayment of advance from affiliate
|
- | (31,745 | ) | (1,250 | ) | |||||||
Net cash provided by financing activities
|
19,647,152 | 19,109,594 | 11,596,750 | |||||||||
EFFECT OF EXCHANGE RATE CHANGES ON CASH
|
(79,936 | ) | 12,829 | 41,972 | ||||||||
INCREASE IN CASH AND CASH EQUIVALENTS
|
114,013 | 7,595,369 | 3,030,319 | |||||||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
14,770,584 | 7,175,215 | 4,144,896 | |||||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 14,884,597 | $ | 14,770,584 | $ | 7,175,215 | ||||||
SUPPLEMENTAL CASH FLOW INFORMATION
|
||||||||||||
Cash paid for income taxes
|
$ | 108,075 | $ | 460,924 | $ | - | ||||||
Non-cash investing activities
|
||||||||||||
Acquisition of intangible assets through issuance of the Company's stock
|
$ | 1,481,462 | $ | 1,442,850 | $ | - | ||||||
Acquisition of business through issuance of the Company's stock
|
$ | - | $ | 14,496,256 | $ | - | ||||||
Issuance of company stock for accrued liabilities and advances
|
$ | - | $ | - | $ | 149,475 |
●
|
Fair Value of Our Common Stock — Our common stock is valued by reference to the publicly-traded price of our common stock.
|
●
|
Expected Volatility — Prior to the Eastbridge merger, we did not have a history of market prices for our common stock and since the merger, we do not have what we consider a sufficiently active and readily traded market for our common stock to use historical market prices for our common stock to estimate volatility. Accordingly, we estimate the expected stock price volatility for our common stock by taking the median historical stock price volatility for industry peers based on daily price observations over a period equivalent to the expected term of the stock option grants. Industry peers consist of other public companies in the stem cell industry similar in size, stage of life cycle and financial leverage. We intend to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information regarding the volatility of our own common stock share price becomes available.
|
●
|
Risk-Free Interest Rate — The risk-free interest rate assumption is based on observed interest rates appropriate for the expected terms of our awards. The risk-free interest rate assumption is based on the yields of U.S. Treasury securities with maturities similar to the expected term of the options for each option group.
|
●
|
Expected Term — The expected term represents the period that our stock-based awards are expected to be outstanding. The expected terms of the awards are based on a simplified method which defines the life as the average of the contractual term of the options and the weighted-average vesting period for all open tranches.
|
●
|
Expected Dividend Yield — We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.
|
Cash
|
$ | 145,611 | ||
Accounts receivable
|
151,093 | |||
Other receivable
|
31,798 | |||
Inventory
|
174,820 | |||
Prepaid expenses
|
14,331 | |||
Property, plant and equipment, net
|
561,113 | |||
Intangible assets
|
9,942,000 | |||
Goodwill
|
7,678,786 | |||
Long-term prepaid expenses
|
83,054 | |||
Total assets acquired
|
18,782,606 | |||
Accounts payables
|
(47,509 | ) | ||
Accrued expenses
|
(42,013 | ) | ||
Other current liabilities
|
(523,077 | ) | ||
Other non current liabilities
|
(422,592 | ) | ||
Total liabilities assumed
|
(1,035,191 | ) | ||
Net assets acquired
|
$ | 17,747,415 |
Year Ended December 31, 2014
|
Year Ended December 31, 2013
|
||||||||||||||||||||||
CBMG
|
Agreen
|
Pro forma
|
CBMG
|
Agreen
|
Pro forma
|
||||||||||||||||||
As stated
|
Pro forma Adjustment
|
Consolidated
|
As stated
|
Pro forma Adjustment
|
Consolidated
|
||||||||||||||||||
Net sales and revenue
|
$ | 564,377 | $ | 1,198,414 | $ | 1,762,791 | $ | 204,914 | $ | 1,075,692 | $ | 1,280,606 | |||||||||||
Net loss
|
(15,474,611 | ) | (48,109 | ) | (15,522,720 | ) | (13,797,033 | ) | (338,804 | ) | (14,135,837 | ) | |||||||||||
Weighted average common shares outstanding:
|
|||||||||||||||||||||||
Basic
|
8,627,094 | 555,335 | 9,182,429 | 5,792,888 | 753,522 | 6,546,410 | |||||||||||||||||
Diluted
|
8,627,094 | 555,335 | 9,182,429 | 5,792,888 | 752,522 | 6,545,410 | |||||||||||||||||
Earnings (loss) per share net loss:
|
|||||||||||||||||||||||
Basic
|
$ | (1.79 | ) | $ | (0.09 | ) | $ | (1.69 | ) | $ | (2.38 | ) | $ | (0.45 | ) | $ | (2.16 | ) | |||||
Diluted
|
$ | (1.79 | ) | $ | (0.09 | ) | $ | (1.69 | ) | $ | (2.38 | ) | $ | (0.45 | ) | $ | (2.16 | ) |
Year Ended December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Amounts reclassified:
|
||||||||||||
Consulting revenue
|
$ | - | $ | 1,612,746 | $ | 3,864,586 | ||||||
Consulting operating expenses
|
- | (1,352,189 | ) | (1,308,488 | ) | |||||||
Selling and marketing
|
- | (27,673 | ) | (70,069 | ) | |||||||
Impairment expense
|
- | (3,299,566 | ) | (4,258,967 | ) | |||||||
Other income (expense)
|
- | (1,725 | ) | (321,130 | ) | |||||||
Income tax provision
|
- | (50,745 | ) | (344,446 | ) | |||||||
Total amount reclassified as discontinued operations
|
$ | - | $ | (3,119,152 | ) | $ | (2,438,514 | ) |
December 31,
|
December 31,
|
|||||||
2015
|
2014
|
|||||||
Assets
|
||||||||
Cash
|
$ | 1,821,883 | $ | 3,496,678 | ||||
Accounts receivable
|
337,345 | 141,029 | ||||||
Other receivables
|
136,621 | 127,280 | ||||||
Inventory
|
180,973 | 215,152 | ||||||
Prepaid expenses
|
250,123 | 193,613 | ||||||
Other current assets
|
- | 109,777 | ||||||
Total current assets
|
2,726,945 | 4,283,529 | ||||||
Property, plant and equipment, net
|
1,145,924 | 1,055,648 | ||||||
Intangibles
|
1,892,551 | 42,779 | ||||||
Long-term prepaid expenses and other assets
|
349,653 | 126,503 | ||||||
Total assets
|
$ | 6,115,073 | $ | 5,508,459 | ||||
Liabilities
|
||||||||
Accounts payable
|
$ | 38,004 | $ | 10,572 | ||||
Other payables
|
914,817 | 714,309 | ||||||
Payroll accrual
|
464,510 | 273,599 | ||||||
Taxes payable
|
- | - | ||||||
Total current liabilities
|
$ | 1,417,331 | $ | 998,480 | ||||
Other non-current liabilities
|
60,829 | 436,346 | ||||||
Total liabilities
|
$ | 1,478,160 | $ | 1,434,826 |
December 31, 2015
|
December 31, 2014
|
|||||||
Raw materials
|
$ | 357,896 | $ | 128,665 | ||||
Work in progress
|
- | 89,164 | ||||||
Semi-finished goods
|
15,346 | - | ||||||
Finished goods
|
17,644 | 154,420 | ||||||
$ | 390,886 | $ | 372,249 |
December 31, 2015
|
December 31, 2014
|
|||||||
Office equipment
|
$ | 24,526 | $ | 16,842 | ||||
Manufacturing equipment
|
2,680,805 | 1,518,718 | ||||||
Computer equipment
|
150,698 | 73,888 | ||||||
Leasehold improvements
|
1,417,997 | 1,414,475 | ||||||
Construction in progress
|
680,740 | - | ||||||
4,954,766 | 3,023,923 | |||||||
Less: accumulated depreciation
|
(2,185,866 | ) | (1,743,513 | ) | ||||
$ | 2,768,900 | $ | 1,280,410 |
December 31, 2015
|
Cost
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses more than 12 months
|
|
Gross Unrealized Losses less than 12 months
|
|
Market or Fair Value
|
||||||||||
Equity position in Alpha Lujo, Inc.
|
$
|
251,388
|
$
|
-
|
$
|
-
|
$
|
(133,694)
|
$
|
117,694
|
||||||||
Equity position in Arem Pacific Corporation
|
5,030,000
|
170,000
|
-
|
-
|
5,200,000
|
|||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
61,713
|
-
|
-
|
-
|
61,713
|
|||||||||||||
Total
|
$
|
5,343,101
|
$
|
170,000
|
$
|
-
|
$
|
(133,694)
|
$
|
5,379,407
|
December 31, 2014
|
Cost
|
Gross Unrealized Gains
|
Gross Unrealized Losses more than 12 months
|
|
Gross Unrealized Losses less than 12 months
|
|
Market or Fair Value
|
|||||||||||
Equity position in Alpha Lujo, Inc.
|
$
|
251,388
|
$
|
42,846
|
$
|
-
|
$
|
-
|
$
|
294,234
|
||||||||
Equity position in Arem Pacific Corporation
|
5,030,000
|
1,370,000
|
-
|
-
|
6,400,000
|
|||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
191,799
|
-
|
-
|
-
|
191,799
|
|||||||||||||
Total
|
$
|
5,473,187
|
$
|
1,412,846
|
$
|
-
|
$
|
-
|
$
|
6,886,033
|
As of December 31, 2015
|
||||||||||||||||
Fair Value Measurements at Reporting Date Using:
|
||||||||||||||||
Quoted Prices in
|
Significant Other
|
Significant
|
||||||||||||||
Active Markets for
|
Observable
|
Unobservable
|
||||||||||||||
Identical Assets
|
Inputs
|
Inputs
|
||||||||||||||
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Equity position in Alpha Lujo, Inc.
|
$ | 117,694 | $ | - | $ | 117,694 | $ | - | ||||||||
Equity position in Arem Pacific Corporation
|
5,200,000 | - | 5,200,000 | - | ||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
61,713 | - | 61,713 | - | ||||||||||||
$ | 5,379,407 | $ | - | $ | 5,379,407 | $ | - |
As of December 31, 2014
|
||||||||||||||||
Fair Vaue Measurements at Reporting Date Using:
|
||||||||||||||||
Quoted Prices in
|
Significant Other
|
Significant
|
||||||||||||||
Active Markets for
|
Observable
|
Unobservable
|
||||||||||||||
Identical Assets
|
Inputs
|
Inputs
|
||||||||||||||
Total
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
Assets:
|
||||||||||||||||
Equity position in Alpha Lujo, Inc.
|
$ | 294,234 | $ | - | $ | 294,234 | $ | - | ||||||||
Equity position in Arem Pacific Corporation
|
6,400,000 | - | 6,400,000 | - | ||||||||||||
Equity position in Wonder International Education & Investment Group Corporation
|
191,799 | - | 191,799 | - | ||||||||||||
$ | 6,886,033 | $ | - | $ | 6,886,033 | $ | - |
December 31, 2015
|
December 31, 2014
|
|||||||
Cost basis
|
$ | 17,686,700 | $ | 11,404,730 | ||||
Less: accumulated amortization
|
(1,790,045 | ) | (289,758 | ) | ||||
$ | 15,896,655 | $ | 11,114,972 |
December 31, 2015 |
December 31, 2014
|
|||||||
Cost basis
|
$ | 90,951 | $ | 65,848 | ||||
Less: accumulated amortization
|
(38,506 | ) | (24,144 | ) | ||||
$ | 52,445 | $ | 41,704 | |||||
Total intangibles, net
|
$ | 15,949,100 | $ | 11,156,676 |
Years ending December 31,
|
Amount
|
|||
2016
|
$ | 1,786,860 | ||
2017
|
1,785,492 | |||
2018
|
1,776,513 | |||
2019
|
1,775,602 | |||
2020 and thereafter
|
8,824,633 | |||
$ | 15,949,100 |
Years ending December 31,
|
Amount
|
|||
2016
|
$ | 1,015,863 | ||
2017
|
485,968 | |||
2018
|
474,433 | |||
2019
|
450,492 | |||
2020 and thereafter
|
622,253 | |||
$ | 3,049,009 |
December 31, 2015
|
||||
Contracts for acquisition of equipment and GMP construction being or to be executed
|
$ | 193,373 | ||
Contracts for acquisition of intangible assets being or to be executed
|
- | |||
$ | 193,373 |
Number of Options
|
Weighted- Average
Exercise Price
|
Weighted- Average Remaining Contractual Term (in years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Outstanding at December 31, 2013
|
705,073 | $ | 4.19 | 9.2 | $ | 735,132 | ||||||||||
Grants
|
795,500 | 10.53 | ||||||||||||||
Forfeitures
|
(71,750 | ) | 5.06 | |||||||||||||
Exercises
|
(3,650 | ) | 5.31 | |||||||||||||
Outstanding at December 31, 2014
|
1,425,173 | $ | 7.37 | 8.9 | $ | 11,065,770 | ||||||||||
Grants
|
721,779 | 20.89 | ||||||||||||||
Forfeitures
|
(41,900 | ) | 15.58 | |||||||||||||
Exercises
|
(152,404 | ) | 4.48 | |||||||||||||
Outstanding at December 31, 2015
|
1,952,648 | $ | 12.42 | 7.8 | $ | 17,701,962 | ||||||||||
Vested and exercisable at December 31, 2015
|
860,444 | $ | 7.51 | 7.5 | $ | 12,029,468 |
Exercise
|
Number of Options
|
|||
Price
|
Outstanding
|
Exercisable
|
||
$3.00 - $4.95
|
279,033
|
265,146
|
||
$5.00 - $9.19
|
701,186
|
390,352
|
||
$12.91 +
|
972,429
|
204,946
|
||
1,952,648
|
860,444
|
For the Year Ended
|
||||||||||||
December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Loss from continuing operations
|
$ | (19,447,721 | ) | $ | (12,355,459 | ) | $ | (11,358,519 | ) | |||
Loss on discontinued operations
|
$ | - | $ | (3,119,152 | ) | $ | (2,438,514 | ) | ||||
Net loss
|
$ | (19,447,721 | ) | $ | (15,474,611 | ) | $ | (13,797,033 | ) | |||
Weighted average shares of common stock
|
11,472,306 | 8,627,094 | 5,792,888 | |||||||||
Dilutive effect of stock options
|
- | - | - | |||||||||
Restricted stock vested not issued
|
- | - | - | |||||||||
Common stock and common stock equivalents
|
11,472,306 | 8,627,094 | 5,792,888 | |||||||||
Loss from continuing operations per basic share | $ | (1.70 | ) | $ | (1.43 | ) | $ | (1.96 | ) | |||
Loss from continuing operations per diluted share | $ | (1.70 | ) | $ | (1.43 | ) | $ | (1.96 | ) | |||
Loss on discontinued operations per basic share | $ | - | $ | (0.36 | ) | $ | (0.42 | ) | ||||
Loss on discontinued operations per diluted share | $ | - | $ | (0.36 | ) | $ | (0.42 | ) | ||||
Net loss per basic share | $ | (1.70 | ) | $ | (1.79 | ) | $ | (2.38 | ) | |||
Net loss per diluted share | $ | (1.70 | ) | $ | (1.79 | ) | $ | (2.38 | ) |
For the Year Ended
|
||||||||||||
December 31,
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
Current:
|
||||||||||||
US federal
|
$ | (733,158 | ) | $ | 41,798 | $ | 339,856 | |||||
US state
|
4,557 | 8,947 | 4,590 | |||||||||
Foreign
|
- | - | - | |||||||||
Total current tax (credit) expense
|
$ | (728,601 | ) | $ | 50,745 | $ | 344,446 | |||||
Deferred:
|
||||||||||||
Federal
|
$ | - | $ | - | $ | - | ||||||
State
|
- | - | - | |||||||||
Foreign
|
- | - | - | |||||||||
Total deferred tax expense
|
$ | - | $ | - | $ | - | ||||||
Total income tax (credit) expense
|
$ | (728,601 | ) | $ | 50,745 | $ | 344,446 |
December 31,
|
December 31,
|
|||||||
2015
|
2014
|
|||||||
Deferred tax assets:
|
||||||||
Net operating loss carry forwards (offshore)
|
$ | 1,994,281 | $ | 4,343,930 | ||||
Net operating loss carry forwards (US)
|
2,300,322 | 1,823,432 | ||||||
Accruals (offshore)
|
176,859 | - | ||||||
Accrued compensation (US)
|
36,177 | 581,129 | ||||||
Stock-based compensation (US)
|
1,430,243 | 1,217,927 | ||||||
Investments (US)
|
1,683,237 | 599,332 | ||||||
Credits (US)
|
72,004 | - | ||||||
Subtotal
|
7,693,123 | 8,565,750 | ||||||
Less: valuation allowance
|
(7,663,450 | ) | (8,565,750 | ) | ||||
Total deferred tax assets
|
29,673 | - | ||||||
Deferred tax liabilities:
|
||||||||
Property and equipment
|
(1,377 | ) | - | |||||
Goodwill & Intangibles
|
(28,296 | ) | - | |||||
Subtotal
|
(29,673 | ) | - | |||||
Net deferred tax asset
|
$ | - | $ | - |
For the Year Ended
|
For the Year Ended
|
For the Year Ended
|
||||||||||
December 31, 2015
|
December 31, 2014
|
December 31, 2013
|
||||||||||
Effective Tax Rate Reconciliation
|
||||||||||||
Income tax provision at statutory rate
|
(35 | )% | (35 | )% | (35 | )% | ||||||
State income taxes, net of federal benefit
|
0 | % | 0 | % | 0 | % | ||||||
Goodwill impairement
|
0 | % | 7 | % | 12 | % | ||||||
Foreign rate differential
|
12 | % | 14 | % | 5 | % | ||||||
Other permanent difference
|
4 | % | 0 | % | (4 | )% | ||||||
Change in valuation allowance
|
15 | % | 14 | % | 25 | % | ||||||
Total tax (credit) expense
|
(4 | )% | 0 | % | 3 | % |
For the Year Ended
|
For the Year Ended
|
|||||||||||||||||||||||
December 31, 2014
|
December 31, 2013
|
|||||||||||||||||||||||
before reclassification
|
reclassification
|
after reclassification
|
before reclassification
|
reclassification
|
after reclassification
|
|||||||||||||||||||
Operating expenses:
|
||||||||||||||||||||||||
Cost of sales
|
$ | 213,243 | $ | 28,972 | $ | 242,215 | $ | 296,212 | $ | - | $ | 296,212 | ||||||||||||
General and administrative
|
8,413,251 | (537,838 | ) | 7,875,413 | 9,314,143 | (151,971 | ) | 9,162,172 | ||||||||||||||||
Selling and marketing
|
280,595 | 34,299 | 314,894 | 57,670 | 605 | 58,275 | ||||||||||||||||||
Research and development
|
2,671,932 | 474,567 | 3,146,499 | 1,890,506 | 151,366 | 2,041,872 | ||||||||||||||||||
Total
|
$ | 11,579,021 | $ | - | $ | 11,579,021 | $ | 11,558,531 | $ | - | $ | 11,558,531 |
Year ended December 31, 2015
|
||||||||||||||||||||
Q4 | Q3 | Q2 | Q1 |
Total
|
||||||||||||||||
Selected Income Statement Data:
|
||||||||||||||||||||
Net sales and revenue
|
$ | 620,167 | $ | 624,907 | $ | 656,959 | $ | 603,390 | $ | 2,505,423 | ||||||||||
Gross Profit
|
75,543 | 181,491 | 258,730 | 109,328 | 625,092 | |||||||||||||||
Loss from continuing operations
|
(4,991,877 | ) | (5,142,198 | ) | (5,026,475 | ) | (4,287,171 | ) | (19,447,721 | ) | ||||||||||
Net loss
|
(4,991,877 | ) | (5,142,198 | ) | (5,026,475 | ) | (4,287,171 | ) | (19,447,721 | ) | ||||||||||
Net loss per share :
|
||||||||||||||||||||
Basic
|
(0.43 | ) | (0.44 | ) | (0.44 | ) | (0.39 | ) | (1.70 | ) | ||||||||||
Diluted
|
(0.43 | ) | (0.44 | ) | (0.44 | ) | (0.39 | ) | (1.70 | ) | ||||||||||
Year ended December 31, 2014
|
||||||||||||||||||||
Q4 | Q3 | Q2 | Q1 |
Total
|
||||||||||||||||
Selected Income Statement Data:
|
||||||||||||||||||||
Net sales and revenue
|
$ | 385,257 | $ | - | $ | 118,069 | $ | 61,051 | $ | 564,377 | ||||||||||
Gross Profit
|
235,595 | - | 66,116 | 20,451 | 322,162 | |||||||||||||||
Loss from continuing operations
|
(5,448,899 | ) | (2,780,009 | ) | (2,265,345 | ) | (1,861,206 | ) | (12,355,459 | ) | ||||||||||
Net loss
|
(5,530,537 | ) | (2,823,280 | ) | (6,674,263 | ) | (446,531 | ) | (15,474,611 | ) | ||||||||||
Net loss per share :
|
||||||||||||||||||||
Basic
|
(0.55 | ) | (0.31 | ) | (0.85 | ) | (0.06 | ) | (1.79 | ) | ||||||||||
Diluted
|
(0.55 | ) | (0.31 | ) | (0.85 | ) | (0.06 | ) | (1.79 | ) |
(i)
|
a material breach by the Consultant of his obligations under this Agreement;
|
(ii)
|
intentional non-performance or mis-performance of Consultant’s Services, or, in the sole judgment of the Chief Executive Officer, the refusal to abide by or comply with the directives of the Chief Executive Officer or the Company's policies and procedures;
|
(iii)
|
conviction of, or a plea of nolo contendere to, a felony or other crime involving moral turpitude provided such conviction is not the result of the Consultant carrying out his Services under this Agreement for the Company (given the nature of the Company’s business activities);
|
(iv)
|
Consultant’s gross negligence in the performance of his Services under this Agreement;
|
(v)
|
Consultant’s willful dishonesty, fraud or misconduct with respect to the business or affairs of the Company, that in the sole judgment of the Company’s Board of Directors, materially and adversely affects the Company;
|
(vi)
|
Consultant’s commission of any willful act in direct competition with or materially detrimental to the best interests of Company; or
|
(vii)
|
misappropriation by the Consultant of any material amount of funds, property, or rights of the Company.
|
CONSULTANT
|
CELLULAR BIOMEDICINE GROUP, INC.
|
||||
By: |
/s/Wei (William) Cao
|
By: |
/s/ Bizuo (Tony) Liu
|
||
Wei (William) Cao
|
Name: Bizuo (Tony) Liu
|
||||
|
Title: Chief Executive Officer
|
1.
|
As directed by the Chief Executive Officer of the Company (the “
Executive
”), advise the Executive on M&A and other strategic opportunities, especially international opportunities in the pharmaceutical industry, and to assist the Company evaluating/exploring future international expansion.
|
2.
|
As directed by the Executive, advise the Company on KOA and stem cell and immune cell (cancer therapy) discussions with technical leaders in connection with the Company’s R&D and expansion efforts.
|
3.
|
Participate in the Company’s internal scientific reviews and actively work with the Company’s Scientific Advisory Board.
|
4.
|
Support the Executive and others in connection with financing, recruitment and other activities as requested by Executive. Consultant shall make himself reasonably available for consultation, either in person or by phone, email or video conference, on an as-needed basis.
|
5.
|
Timely provide all necessary information and assistance to the Company and take all action requested by the Company in order to effect the transfer of Consultant’s role as a representative of the Company’s subsidiaries or controlled entities to a new Company designee, including but not limited to Consultant’s resignation from any and all positions with the Company’s subsidiaries or variable interest entities, transfer of any equity interest in [Cellular Biomedicine Group Ltd. (Shanghai)], and the transfer or removal of signatory status, legal representative status, or bank account access authorization in connection therewith.
|
6.
|
Provide other related services and advice to the Company as agreed by the parties from time to time.
|
1.
|
Any unvested portion of the Non-Qualified Stock Option with an exercise price of $15.53 issued to the Consultant pursuant to that certain Stock Option Award Agreement dated December 31, 2014 will vest until February 4, 2017 at the existing monthly rate. The options will have an expiration date of August 6, 2017. After February 4, 2017, vesting will continue monthly for up to another six (6) months as long as this Agreement is effective. However, after the termination of this Agreement, all vesting will cease. Notwithstanding the above, if the Consultant ceases to serve as a director of the Company prior to February 6, 2017, he will be deemed to have forfeited such options and any unvested options will vest and expire pursuant to the terms of the above-referenced Stock Option Award Agreement.
|
2.
|
Any unvested portion of the Non-Qualified Stock Option issued to Consultant pursuant to that certain Stock Option Award Agreement dated February 20, 2013 shall immediately vest in full on February 6, 2016 pursuant to the Company’s Notice of Termination to Consultant dated January 5, 2016 and shall expire on February 6, 2017.
|
3.
|
Options granted in September 2013 shall cease vesting February 6, 2016 and shall expire February 6, 2017.
|
4.
|
Any other options held by Consultant will cease to vest on February 6, 2016 and will expire on February 7, 2016 pursuant to the terms of their respective option award agreements.
|
|
(III) The patent application number of above four invention patents has been issued by State Intellectual Property Office of the PRC; while no authorization is permitted. Party A agrees to exclusively transferring the application right for four technologies and patents to Party B once. Where it is declared as invalid or no patent is obtained, above technologies shall be deemed as non-patented technology transfer and the Contract shall be performed continuously, with relevant transfer conditions and both parties’ rights and obligations remaining unchanged.
|
Party A (seal):
General Hospital of the Chinese People’s Liberation Army
|
Party B (seal):
Cellular Biomedicine Group (Shanghai) Ltd
|
Legal representative: Li Shuzhang (Seal)
|
Legal representative: /s/ Cao Wei
|
Project leader:
|
Project leader:
|
Date: February 4, 2015
|
Date: February 4, 2015
|
SN
|
Patent applicant
|
Category
|
Inventor
|
Patent application date (application No.)
|
Name of invention
|
Legal status
|
Introduction of patent
|
|||||||
1
|
PersonGen Biomedicine (Suzhou) Co., Ltd.
|
Invention
|
Yang Lin, Li Yafen, Zong Yunhui
|
2015. 01. 06
|
Improved aAPC technology and its application in immune cell preparation (pending, the ultimate name depends on the actual application result)
|
under application
|
It is applicable to the production and preparation of CAR—T cell, CAR—NK cell
|
|||||||
2
|
PersonGen Biomedicine (Suzhou) Co., Ltd.
|
Invention
|
Yang Lin, Chu Fuliang, Zong Yunhui
|
2014. 11. 06 (201410613502.1)
|
SN of PD—1 resistant single cloning antibody variable area; preparation methods and application
|
Applied already
|
It is able to block PD—1 from integrating with the body; it is applicable to the immune treatment of numerous malignant tumors.
|
|||||||
3
|
PersonGen Biomedicine (Suzhou) Co., Ltd.
|
Invention
|
Yang Lin, Zou Jianxuan, Chen Dan
|
2015. 01. 06
|
SN of CD 19 resistant single cloning antibody variable area; preparation methods and application (pending, the ultimate name depends on the actual application result)
|
under application
|
It is applicable to building CAR—T of targeted leukemia and lymphoma; double specific antibody of CD3/CD19 gene project.
|
|||||||
4
|
PersonGen Biomedicine (Suzhou) Co., Ltd
|
Invention
|
Yang Lin, You Fengtao, Jiang Licui
|
2015. 01. 10
|
Application of 3
rd
generation of CAR (pending, the ultimate name depends on the actual application result)
|
under application
|
It is applicable to the cell treatment of malignant tumors.
|
1.
|
The patent application documents of target technologies shall include (but not limited to):
|
1)
|
All the patent application documents submitted to the National Patent Office, including specification, right claim, attached drawings, abstract and its attached drawings, letter of request, statement of opinions, changes in document matters, audit and approval decision of right resuming upon lose of rights and authorized consignment letter.
|
2)
|
All the documents distributed by National Patent Office to the transferor, including acceptance notice, midterm documents and authorization decision.
|
3)
|
Patent application and execution permit contract (if applicable) approved by the transferor to other party, including contract appendix (technical and process documents related to patent application).
|
4)
|
Effective certificate on patent application right issued by National Patent Office: Latest voucher of patent application and maintenance expense (or registration booklet of National Patent Office on patent legal status).
|
5)
|
Certificate of National Patent Office or other competent department adopted to approve transfer of target technologies to the transferee.
|
|
2. Technical documents of each target technology
|
1)
|
Technical secret and ingredient
|
2)
|
Product production process route
|
3)
|
Standard production flow
|
4)
|
Quality control standard of products
|
5)
|
Test data, test report and technical documentary
|
|
3. aAPC technology
|
1)
|
Structural drawing
|
2)
|
Building methods
|
3)
|
Preparation SOP of cell T
|
4)
|
Preparation SOP of cell NK
|
5)
|
aAPC cell line
|
|
4. PD—1 technology
|
1)
|
scFv sequence
|
2)
|
Biological function data
|
3)
|
Biochemical parameters and data
|
4)
|
PD—1 single cloning antibody hybridoma cell line
|
5)
|
PD—1 antigen (standard PD—1 antigen protein in 5mg or re-organized particle adopted to efficiently express solutable human gene re-organized PD—1 protein)
|
|
5. CD 19 technology
|
1)
|
scFv sequence
|
2)
|
Biological data
|
3)
|
CD 19 single cloning antibody hybridoma cell line
|
4)
|
CD 19 antigen (standard CD 19 antigen protein in 5mg or re-organized particle adopted to efficiently express solutable human gene re-organized CD 19 protein)
|
|
6. 3
rd
generation of CAR technology
|
1)
|
Structural drawing
|
2)
|
Full sequence
|
3)
|
SOP building
|
4)
|
Carrier DNA (10 ug)
|
1.
|
Legality. The transferor shall refer to a limited liability company registered and existent according to the Chinese laws; it shall possess the legal person’s qualification.
|
2.
|
Legal authorization. On the agreement signing date, the transferor and main inventor have obtained legal and effective internal and external authorization aimed at the agreement; the signet on behalf of the transferor shall refer to the transferor’s legal representative or legal authorized representative.
|
3.
|
Compulsory execution. According to the agreement articles and conditions, the agreement shall be legal and effective to the transferor and main inventor and shall be legally binding and enjoy compulsory execution.
|
4.
|
No right defect
|
1)
|
The list of target technologies in Appendix I has disclosed all the intellectual property rights of target technologies transferred by the transferor.
|
2)
|
Before the agreement signing date and closing date, the transferor shall refer to the legal patentee of target technologies and exclusive patent application patentee; it shall enjoy complete intellectual property right and equity to all the target technologies; such rights shall be favorable, complete, sustainably effective and compulsorily executed.
|
3)
|
The relationship between inventor and target technology listed in Appendix I shall refer to the relationship of working post invention and creation; it shall not enjoy any patent application right, patent right or other property right to the target technology. The main inventor, transferor’s research and development delegate, other employees, consultants, associated parties or any other third party shall not raise any right claim or request to the assignee. The target technology and intellectual property right shall not suffer from any pledge, reservation or other form of assurance or right burden.
|
4)
|
The target technology shall enjoy advanced, practical and reliable properties and shall not infringe or steal any third party’s intellectual property right or other legal rights and not suffer from conflict against any third party’s intellectual property right. No third party has ever raised any objection or claim to the transferor by reason of infringement upon target technology.
|
5)
|
By the end of the agreement signing date and delivery date, no entity is engaged in the infringement upon transferor’s any intellectual property right on target technology according to the knowledge of transferor and main inventor. The target technology and intellectual property right shall not be restricted by any verdict or any property of command; there shall be no suspended or potential objection, lawsuit, investigation, appeal, claim or request affecting the legality, execution feasibility, use right or ownership of intellectual property right.
|
6)
|
The transferor and main inventor shall not offer (spoken or written) any third party with the use permit or other right on target technology; shall not personally or permit any third party to make patent application and obtain patent registration in any country and region.
|
7)
|
The transferor and main inventor have adopted adequate and effective confidential measures to the technical secrets of target technology and failed to disclose target technology to any other person beyond the core technical team.
|
1.
|
Legality. The transferee shall refer to a limited liability company registered and existent according to the Chinese laws; it shall possess the legal person’s qualification.
|
2.
|
Legal authorization. On the agreement signing date, the transferee has obtained legal and effective internal and external authorization aimed at the agreement; the signet on behalf of the transferee shall refer to the transferee’s legal representative or legal authorized representative.
|
3.
|
Compulsory execution. According to the agreement articles and conditions, the agreement shall be legal and effective to the transferee and shall be legally binding and enjoy compulsory execution.
|
4.
|
The transferee shall promise to provide any documents or materials for the transferor based on all the agreement rights and obligations in a true and effective manner.
|
1
|
Since Party A, as the sponsor, expects that Party B conducts clinical trial under the clinical research scheme of
Single Center, Random and Double Bland Stage I Clinical Research on Evaluation of Safety and Effectiveness of Autologous Adipose-derived Mesenchymal Cell Therapy of KOA
(hereinafter referred to as “clinical trial” or “trial”) through Prof. Bao Chunde, an investigator jointly approved by the two parties;
|
2
|
Since Party B and the investigator
Prof. Bao Chunde
agree to conduct clinical trial under the clinical research scheme of
Single Center, Random and Double Bland Stage I Clinical Research on Evaluation of Safety and Effectiveness of Autologous Adipose-derived Mesenchymal Cell Therapy of KOA
for Party A;
|
1
|
The number of qualified cases selected shall be at least 18;
|
2
|
The number of qualified cases completing all courses of treatment and follow-up visits shall be at least 18.
|
1
|
The date of selection of the final qualified case is June 30, 2016.
|
2
|
The date when the final qualified case completes all courses of treatment and follow-up visits is June 30, 2017.
|
1
|
Take charge of initiating, applying, organizing, subsidizing and supervising this clinical trial.
|
2
|
Join hands with Party B to formulate a clinical trial scheme.
|
3
|
Follow relevant laws and regulations of the People’s Republic of China on clinical trials and Declaration of Helsinki and start to organize clinical trial according to clinical trial scheme after obtaining the consent from ethics committee of trial unit or ethics committee of group leader unit.
|
4
|
Provide an investigator manual introducing detailed information of new medical technologies used in this clinical trial.
|
5
|
Provide new medical technologies complying with relevant regulations including national laws and regulations.
|
6
|
Supervise, audit and inspect this trial on a regular basis according to relevant laws and regulations including
Measures for Administration of Clinical Application of Medical Technologies
and
Quality Management Code of Drug Clinical Trial
. Such supervision, audit and inspection can be carried out by supervisor, auditor and inspector designated by Party A and accepted by Party B, or personnel from review institution designated by Ministry of Health and China Food and Drug Administration.
|
7
|
Provide Party B with clinical trial fund according to stipulations set out in Article 9 of this agreement.
|
8
|
Take charge of establishing clinical trial quality control and quality assurance system and organizing supervision and audit of clinical trial when necessary to ensure quality.
|
9
|
Join hands with Party B to quickly investigate serious adverse events incurred, take necessary measures to ensure the safety of the subjects, timely report to relevant supervision management department, and meanwhile notify serious adverse events to other investigators involved in clinical trial of same medical technology.
|
10
|
Submit summary report of trial to medical technology review institution designated by Ministry of Health, China Food and Drug Administration or relevant governmental department or put forward report of trial termination and reasons.
|
11
|
When Party B conducts clinical trial without following the approved scheme,
Measures for Administration of Clinical Application of Medical Technologies
and
Quality Management Code of Drug Clinical Trial
or relevant regulations, Party A shall point out to correct Party B’s behavior. If the situation is serious or continuously remains unchanged, Party B shall be terminated to participate in clinical trial and report to relevant supervision management department.
|
12
|
Party A shall have already provided relevant insurance according to
Quality Management Code of Drug Clinical Trial
in order to undertake therapy expenses and relevant economic compensation for damages or deaths taking place to patients complying with selection standards during participation in research as having cause-and-effect relationship with clinical trial. Party A shall actively rescue patients during research process if serious adverse events and adverse events beyond the compensation provisions of the insurance policy and offer relevant economic compensation.
|
13
|
Party A will not compensate any damage caused to the patients due to medical accident caused by Party B or investigator or violation of clinical trial scheme according to the requirements of
Quality Management Code of Drug Clinical Trial
.
|
14
|
Abide by
Measures for Administration of Clinical Application of Medical Technologies
,
Quality Management Code of Drug Clinical Trial
and relevant laws and regulations of the People’s Republic of China.
|
1
|
Acquire and maintain the qualification to engage in clinical trial and have professional knowledge, experience, etc. required in trial scheme.
|
2
|
Select cases, organize implementation and keep detailed records according to specific requirements of clinical trial under this agreement.
|
3
|
Abide by
Measures for Administration of Clinical Application of Medical Technologies
,
Quality Management Code of Drug Clinical Trial
and relevant laws and regulations as well as provisions of
Clinical Trial Scheme
and coordinate with trial supervisor/auditor/inspector to ensure trial quality.
|
4
|
Ensure sufficient time, qualified place and disposable personnel with clinical trial qualification to take charge of and complete clinical trial within a time limit stipulated in the scheme.
|
5
|
Explain detailed conditions of relevant clinical trial agreed by ethics committee for disclosure to the subjects and acquire its properly signed informed consent form.
|
6
|
Take charge of making medical decisions related to clinical trial to ensure that the subjects are properly treated when adverse event occurs during clinical trial.
|
7
|
Take necessary measures to guarantee safety and proper recording of the subjects. If a serious adverse event takes place during clinical trial, Party B shall immediately take proper therapeutic measures to the subjects, meanwhile report drug supervision management department, Party A and ethics committee and sign its name and specify the date on the report.
|
8
|
Before terminating or suspending clinical trial ahead of time, Party B must inform the subjects, Party A, ethics committee, China Food and Drug Administration, or relevant government department and explain the reasons.
|
9
|
If the subjects die or suffer from serious damages due to violation of
Clinical Trial Scheme
and
Quality Management Code of Drug Clinical Trial
by Party B or investigator, or due to medical accident caused by Party B or investigator, Party B shall undertake treatment expenses and relevant compensatory liability therefore incurred beyond the compensation scope of insurance.
|
10
|
Draft summary report and take charge of publication of dissertation after completion of clinical trial, sign name, specify relevant date and then send a copy to Party A.
|
11
|
Confidentiality
|
●
|
Party B (including trial director and all personnel involved in the trial) shall take active measures to remain strictly confidential for the confidential information during effective term of this agreement and within ten years after termination of this agreement. Party B shall not disclose such information to any third party or use such information for any other purpose beyond this agreement unless otherwise stipulated herein.
|
●
|
Confidential information refers to classified information received by Party B (including trial director and all personnel involved in clinical trial) from Party A during effective term of this agreement or classified information generated, created or acquired during performing of this agreement and related to the trial, including but not limited to clinical trial scheme, research specimen, research results and reports.
|
1
|
Party A has the right to decide if the equipment necessary to this clinical trial is necessary to this clinical trial and if equipment necessary to this clinical trial is provided at its discretion;
|
2
|
Equipment necessary to this clinical trial can only be used in clinical trial in a way instructed by Party A in writing;
|
3
|
Equipment necessary to this clinical trial must be put in a safe place. Only research personnel designated by the research are responsible for entering research data;
|
4
|
Information related to the interviewed subjects shall be handled using stipulated method within three days after the subjects are accessed or detection data of subjects is received (if applicable);
|
5
|
All data inquiry requirements of Party A shall be completed and returned to Party B within three days (within three days during final data sorting period) or within other time limit stipulated by Party A;
|
6
|
Party B will take proper measures and methods to prevent equipment necessary to this clinical trial and/or software system from being stolen, damaged and lost;
|
7
|
After completion of clinical trial, Party B will return training data and documents related to equipment necessary to the clinical trial as provided for Party B or research personnel.
|
I.
|
Principal investigator (PI) coordination fee: RMB
50,000.00
Yuan in total.
|
II.
|
Clinical research fee of department of rheumatism: RMB
18,500.00
Yuan/each qualified case. The total clinical research fee of 18 cases is RMB
333,000.00
Yuan, including:
|
1.
|
Clinical observation and treatment fee: RMB
15,000.00
Yuan/each qualified case. See Appendix 1 for details;
|
2.
|
Case examination fee: RMB
3,500.00
Yuan/each qualified case. See Appendix 2 for details.
|
III.
|
Amount of screening fee paid by Party A is RMB
2,000.00
Yuan/each failed case (it shall be in line with signing of informed consent form and completion of relevant examinations. After end of clinical trial, Party A and Party B shall pay the amount together with the final installment after confirmation of actual circumstances). This fee is included in case observation fee of department of rheumatism.
|
IV.
|
If the selection progress of patients is obviously slow (i.e. the number of grouped cases in each month is less than 4), Party A may discuss and negotiate with PI concerning relevant arrangements.
|
V.
|
As for cases involved in loss to follow-up and drop-out during clinical follow-up visit, observation fee and examination fee will be paid for this case according to the visit stage completed. The payment of statistically eliminated cases in clinical trial shall be made according to cases with clinical trial completed. The clinical observation fee and clinical examination fee are detailed in the appendix.
|
VI.
|
If Party A provides equipment necessary to clinical trial, the equipment will be returned to Party A after end of clinical trial and upon closing of the research center. Handover sheet of equipment necessary to clinical trial of the two parties in clinical trial shall prevail.
|
1
|
Before startup of clinical trial, PI coordination fee and 20% of clinical research fee of department of rheumatism will be paid as initial capital of clinical research of department of rheumatism (i.e. RMB
116,600.00
Yuan).
|
2
|
After completion of selection of cases as stipulated, 50% of clinical research fee of department of rheumatism (RMB
166,500.00
Yuan) will be paid.
|
3
|
After receiving all trial data and final test summary report, Party A shall pay about 30% of clinical research fee of department of rheumatism (approximately RMB
99,900.00
Yuan) to Party B according to the conditions of actually screened and selected cases.
|
4
|
The transportation subsidy of the subjects shall be paid by the sponsor separately.
|
5
|
If long-term follow-up visit evaluation is needed after end of trial, Party A shall sign a supplementary agreement with Party B separately and pay necessary clinical research fee to Party B. Party B promises that the charging standard of clinical research fee separately supplemented is not higher than the price system of this agreement.
|
6
|
If the number of qualified cases selected by Party B fails to reach the stipulated number after end of test and there is still remaining amount of clinical trial fund prepaid by Party A according to actually selected cases after deduction of relevant clinical trial fee, Party B shall return the remaining amount to Party A.
|
Party A: Cellular Biomedicine Group (Shanghai) Ltd
Cellular Biomedicine Group (Shanghai) Ltd Special Seal for Contract (seal)
|
Party B: Renji Hospital Shanghai Jiaotong University School of Medicine
Renji Hospital Shanghai Jiaotong University School of Medicine
***
(seal)
|
Authorized representative (signature and seal): /s/ Dai Chengxiang (signature)
|
Authorized representative (signature and seal):
***
(signature)
|
Project director:
|
Investigator:
***
(signature)
|
Unit (official seal):
|
Unit (official seal):
|
Date: December 14, 2015
|
Date: December 15, 2015
|
Screening-48W
|
Screening
|
0W
Observation fee and treatment fee
|
1W
|
2W
|
3W
Observation fee and treatment fee
|
4W
|
6W
|
8W
|
12W
|
24W
|
36W
|
48W
|
Total
|
|||||||||||||||||||||||||||||||||||||||
Case screening and observation and treatment fee of department of rheumatism |
2000
|
2000
|
1000
|
1000
|
2000
|
1000
|
1000
|
1000
|
1000
|
1000
|
1000
|
1000
|
15000
|
Unit price
|
Price of follow-up visit
|
Expense
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Item
|
Price
|
V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | V11 | V12 |
Case-time
|
Expense
|
|||||||||||||||||||||||||||||||||||||||||||||
Joint X-ray
|
140 |
√
|
18 | 2520 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ECG
|
25 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 3600 | |||||||||||||||||||||||||||||||||||||||||||||||||
Virology examination
|
290 |
√
|
18 | 5220 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
HIV antibody (40) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Syphilis (60) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
HCV (40) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
HBV (130) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Immunologic test
|
180 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 25920 | |||||||||||||||||||||||||||||||||||||||||||||||||
Blood sugar
|
15 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 2160 | |||||||||||||||||||||||||||||||||||||||||||||||||
Blood fat
|
35 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 5040 | |||||||||||||||||||||||||||||||||||||||||||||||||
LRFT
|
43 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 6192 | |||||||||||||||||||||||||||||||||||||||||||||||||
HCG
|
15 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 2160 | |||||||||||||||||||||||||||||||||||||||||||||||||
Blood routine
|
20 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 2880 | |||||||||||||||||||||||||||||||||||||||||||||||||
Urine routine
|
30 |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
18*8 | 4320 | |||||||||||||||||||||||||||||||||||||||||||||||||
Blood coagulation
|
55 |
√
|
18 | 990 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 61002 |
Name
|
State of Incorporation/Formation
|
|
Cellular Biomedicine Group Ltd.
|
British Virgin Islands
|
|
Cellular Biomedicine Group Ltd.
|
Hong Kong
|
|
Cellular Biomedicine Group (Wuxi) Ltd.
|
People’s Republic of China
|
|
Cellular Biomedicine Group (Shanghai) Ltd.
|
People’s Republic of China (variable interest entity)
|
|
Beijing Agreen Biotechnology Co., Ltd.
|
People’s Republic of China (100% owned by Cellular Biomedicine Group (Shanghai) Ltd.)
|
|
Eastbridge Investment Corporation
|
Delaware
|
|
Cellular Biomedicine Group Vax, Inc.
|
California
|
1.
|
I have reviewed this annual report on Form 10-K of Cellular Biomedicine Group Inc. (the "registrant");
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
Dated:
March 11, 2016
|
By:
|
/s/ Bizuo (Tony) Liu | |
Bizuo (Tony) Liu | |||
Chief Executive Officer and Chief Financial Officer
|
|||
(principal executive officer and financial and accounting officer)
|
Dated:
March 11, 2016
|
By:
|
/s/ Bizuo (Tony) Liu | |
Bizuo (Tony) Liu | |||
Chief Executive Officer and Chief Financial Officer
|
|||
(principal executive officer and financial and accounting officer)
|