SHANGHAI, China and PALO ALTO, Calif., March 31, 2015 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (Nasdaq:CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today reported full-year and fourth quarter 2014 financial results for the period ended December 31, 2014.
"2014 laid the foundation for building a world-class biotechnology enterprise that was marked by achieving notable corporate and clinical milestones and meaningful acquisitions that will drive our business momentum as we move into 2015," said William (Wei) Cao, PhD, BM, Chief Executive Officer of Cellular Biomedicine Group. "In addition to our successful listing on NASDAQ, we accelerated the growth of our Immuno-Oncology platform through the acquisition of Agreen Biotech Co. Ltd. China ("AG"), the acquisition of third generation Chimeric Antigen Receptor T cell (CAR-T), anti-PD-1, CD19 and aAPC cancer immunotherapy technologies from Persongen Biotechnology Ltd., and the acquisition of four CAR-T therapies with corresponding Phase I clinical data and manufacturing knowledge from Chinese PLA General Hospital ("PLAGH", Beijing, also known as "301 Hospital"). The Company's lead product candidate from our Human Adipose-Derived Mesenchymal Progenitor Cell (haMPC) Platform, ReJoinTM for the treatment of Knee Osteoarthritis (KOA), reported positive 12 month results from its Phase IIa clinical trials in 2014 and we are encouraged by the interim Phase IIb clinical data released in the first quarter of 2015 which continues to show excellent progress. We look forward to 2015 as we continue to amalgamate novel cancer technology leaders, deliver promise from our clinical trials to serve several large unmet medical needs in China and seek to evolve into a leader in the biotechnology field."
Tony (Bizuo) Liu, Chief Financial Officer of the Company, commented, "I am pleased to also announce the successful completion of an $18 million private placement transaction in 2014 and $20 million in 2015 which fortified our cash position. We will continue to leverage our financial resources to expand our technology portfolio, strengthen our clinical pipeline, pursue strategic acquisitions, add world-class scientific talent and evaluate multi-national licensing opportunities. We believe these strategic initiatives will further validate our vision of becoming an innovative cell-therapy company that delivers value to our shareholders."
Corporate and Clinical Developments of 2014 and Early 2015
During 2014 and 2015 to date, Cellular Biomedicine Group achieved the following milestones and significant corporate events:
Clinical Developments
1. Announced positive clinical data from Phase I of its CAR-T immuno-oncology clinical development programs of CAR-T CD19 for Acute Lymphocytic Leukemia (B-cell ALL) and CAR-T CD20 for Advanced Diffuse Large B Cell Lymphoma (DLBCL)
2. Launched a clinical study on human adipose derived mesenchymal progenitor cell (haMPC) therapy for Cartilage Damage (CD) resulting from osteoarthritis (OA) or sports injury, which study also serves as a supporting study of ReJoinTM for Knee Osteoarthritis (KOA)
3. Released positive 12-month follow-up data analysis of Phase I/IIa clinical trial for ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) therapy for KOA
4. Announced positive interim 24-week clinical data from the Phase IIb trial of its ReJoinTM haMPC therapy for KOA
Corporate Developments
5. The Company successfully listed onto Nasdaq Capital Markets as the first pure-play cell therapy company from China
6. Closed private placement transactions for total gross proceeds of approximately $38 Million
7. Expanded Intellectual Property portfolio to 69 patents in various stages of approval in China, U.S. and through the Patent Cooperation Treaty (PCT), including one granted US Patent and 15 granted China patents
Fourth Quarter and 2014 Financial Performance
1. Cash Position: Cash and liabilities at December 31, 2014 of approximately $14.8 million and $4.5 million, respectively. (Subsequently, in March 2015, the Company closed a private placement transaction for total gross proceeds of approximately $20,000,000)
2. Net Cash Used in Operating Activities: Q4 and full-year 2014 net cash used in operating activities of $2.2 million and $10.3 million, respectively, compared to $1.3 million and $8.5 million for the same periods in 2013
3. Revenue: Q4 and full-year 2014 revenue of $0.4 million and $0.6 million, respectively, compared to $0.1 million and $0.2 million for the same periods in 2013
4. G&A Expenses: Q4 and full-year 2014 general and administrative expenses of $3.3 million and $8.4 million, respectively, compared to $2.2 million and $9.3 million for the same periods in 2013. Excluding the stock-based compensation of $1.9 million and $1.5 million recorded in G&A expenses for full-year 2014 and 2013, the G&A expenses would have been $6.5 million and $7.8 respectively.
5. R&D Expenses: Q4 and full-year 2014 research and development expenses of $0.8 million and $2.7 million, respectively, compared to $0.6 million and $1.9 million for the same periods a year ago, the increase mainly attributable to significant activities surrounding the development of our biomedicine intellectual property, including the implementation of Phase IIb clinical trials for KOA and launch of the clinical trial for cartilage damage
6. Net Loss: Q4 and full-year 2014 net loss allocable to common stock holders was $5.5 million and $15.5 million, respectively, compared to $6.5 million and $13.8 million for the same periods in 2013. Excluding the stock-based compensation of $1.9 million and $1.5 million recorded for full-year 2014 and 2013, the net loss would have been $13.6 million and $12.3 million respectively.
Primary 2015 Operating Objectives:
1. Publish CAR-T Phase I Clinical Data of CD30 for Hodgkin's lymphoma and EGFR (HER1) for advanced lung cancer
2. Initiate CAR-T Phase II Clinical Trials of CD19, CD20, CD30 and EGFR (HER1)
3. Expand GMP facilities to 47,000 ft2
4. Release 48-week follow-up data from ReJoinTM Phase IIb Clinical Trial
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative diseases and cancers. Our developmental stem cell, progenitor cell, and immune cell projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com.
Forward-Looking Statements
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
CELLULAR BIOMEDICINE GROUP, INC. | ||
(FORMERLY EASTBRIDGE INVESTMENT GROUP CORPORATION) | ||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||
For the Year Ended | ||
December 31, | ||
2014 | 2013 | |
Net sales and revenue | $564,377 | $204,914 |
Operating expenses: | ||
Cost of sales | 213,243 | 296,212 |
General and administrative | 8,413,251 | 9,314,143 |
Selling and marketing | 280,595 | 57,670 |
Research and development | 2,671,932 | 1,890,506 |
Other general expenses | 1,427,840 | -- |
Total operating expenses | 13,006,861 | 11,558,531 |
Operating loss | (12,442,484) | (11,353,617) |
Other income (expense): | ||
Interest income | 15,043 | 1,294 |
Other income (expense) | 71,982 | (6,196) |
Total other income (expense) | 87,025 | (4,902) |
Loss from continuing operations before taxes | (12,355,459) | (11,358,519) |
Income tax provision | -- | -- |
Loss from continuing operations | (12,355,459) | (11,358,519) |
Loss on discontinued operations, net of tax | (3,119,152) | (2,438,514) |
Net loss | $(15,474,611) | $(13,797,033) |
Other comprehensive income (loss): | ||
Cumulative translation adjustment | 15,254 | 78,650 |
Unrecognized gain (loss) on investments | 1,611,045 | (198,200) |
Total other comprehensive income (loss): | 1,626,299 | (119,550) |
Comprehensive loss | $(13,848,312) | $(13,916,583) |
Earnings (loss) per share for continuing operations: | ||
Basic | $(1.43) | $(1.96) |
Diluted | $(1.43) | $(1.96) |
Earnings (loss) per share discontinued operations: | ||
Basic | $(0.36) | $(0.42) |
Diluted | $(0.36) | $(0.42) |
Earnings (loss) per share net loss: | ||
Basic | $(1.79) | $(2.38) |
Diluted | $(1.79) | $(2.38) |
Weighted average common shares outstanding: | ||
Basic | 8,627,094 | 5,792,888 |
Diluted | 8,627,094 | 5,792,888 |
CELLULAR BIOMEDICINE GROUP, INC. | ||
(FORMERLY EASTBRIDGE INVESTMENT GROUP CORPORATION) | ||
CONSOLIDATED BALANCE SHEETS | ||
December 31, | December 31, | |
2014 | 2013 | |
Assets | ||
Cash and cash equivalents | $14,770,584 | $7,175,215 |
Accounts receivable | 141,029 | 10,581 |
Other receivable | 135,957 | 78,521 |
Inventory | 372,249 | 119,119 |
Prepaid expenses | 565,299 | 56,911 |
Other current assets | 110,347 | 134,661 |
Total current assets | 16,095,465 | 7,575,008 |
Investments | 6,886,033 | 5,105,891 |
Property, plant and equipment, net | 1,280,410 | 1,014,805 |
Goodwill | 7,678,789 | 3,299,566 |
Intangibles, net | 11,156,676 | 601,456 |
Long-term prepaid expenses and other assets | 587,729 | -- |
Total assets | $43,685,102 | $17,596,726 |
Liabilities and Stockholders' Equity | ||
Liabilities: | ||
Accounts payable | $426,917 | $213,891 |
Accrued expenses | 2,074,384 | 503,717 |
Tax payable | 814,288 | 1,164,747 |
Advances payable to related party | 36,254 | 67,999 |
Other current liabilities | 724,479 | 251,299 |
Total current liabilities | 4,076,322 | 2,201,653 |
Other non-current liabilities | 452,689 | -- |
Total liabilities | 4,529,011 | 2,201,653 |
Commitments and Contingencies | ||
Stockholders' equity: | ||
Preferred stock, par value $.001, 50,000,000 shares | ||
authorized; none issued and outstanding as of | ||
December 31, 2014 and 2013, respectively | -- | -- |
Common stock, par value $.001, 300,000,000 shares authorized; | ||
10,990,335 and 7,382,797 issued and outstanding | ||
as of December 31, 2014 and 2013, respectively | 10,990 | 7,383 |
Additional paid in capital | 75,467,316 | 37,861,593 |
Accumulated deficit | (37,890,590) | (22,415,979) |
Accumulated other comprehensive income (loss) | 1,568,375 | (57,924) |
Total stockholders' equity | 39,156,091 | 15,395,073 |
Total liabilities and stockholders' equity | $43,685,102 | $17,596,726 |
CELLULAR BIOMEDICINE GROUP, INC. | ||
(FORMERLY EASTBRIDGE INVESTMENT GROUP CORPORATION) | ||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
For the Year Ended | ||
December 31, | ||
2014 | 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $(15,474,611) | $(13,797,033) |
Adjustments to reconcile net loss to net cash | ||
used in operating activities: | ||
Depreciation and amortization | 1,190,505 | 841,235 |
Loss on disposal of assets | 257,672 | -- |
Stock based compensation expense | 1,949,908 | 4,381,077 |
Other than temporary impairment | 1,427,840 | -- |
Impairment of goodwill | 3,299,566 | 4,258,967 |
Third party services received in exchange for disposition of investment stock | -- | 83,334 |
Loss recognized in excess of cash received on disposition of investment stock | 5,913 | 138,909 |
Value of stock received for services | (1,610,000) | (3,500,000) |
Deferred tax | -- | (76,544) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 20,645 | 10,102 |
Other receivable | (25,638) | 50,160 |
Inventory | (78,310) | (81,878) |
Prepaid expenses | (494,057) | (38,793) |
Other current assets | 24,314 | (84,661) |
Investments | 7,150 | -- |
Long-term prepaid expenses and other assets | (504,678) | 134,229 |
Accounts payable | 165,517 | 40,862 |
Accrued expenses | 409,109 | (739,839) |
Other current liabilities | (694,131) | 186,464 |
Taxes payable | (176,583) | (10,121) |
Deferred revenue | -- | (251,834) |
Net cash used in operating activities | (10,299,869) | (8,455,364) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Acquisition of business, net of cash acquired | (1,485,548) | -- |
Purchases of intangibles | (8,989) | (5,828) |
Purchases of assets | (311,625) | (147,211) |
Net cash used in investing activities | (1,806,162) | (153,039) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from the issuance of common stock | 19,700,933 | 11,561,386 |
Proceeds from exercise of stock options | 19,383 | -- |
Repayment of advances from affiliate | (31,745) | (1,250) |
Advances from affiliate | -- | 36,614 |
Net cash provided by financing activities | 19,688,571 | 11,596,750 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 12,829 | 41,972 |
INCREASE IN CASH AND CASH EQUIVALENTS | 7,595,369 | 3,030,319 |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 7,175,215 | 4,144,896 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | $14,770,584 | $7,175,215 |
SUPPLEMENTAL CASH FLOW INFORMATION | ||
Cash paid for income taxes | $460,924 | $-- |
Non cash financing and investing activities: | ||
Issuance of company stock for accrued liabilities and advances | $-- | $149,475 |
Issuance of company stock for acquisition of patent | $1,442,850 | $-- |
Issuance of company stock for acquisition of business | $14,496,256 | $-- |