– Reported Positive Clinical Data from Phase IIb trial of ReJoin® haMPC therapy
– Expanded Stem Cell Platform with the Launch of New Allogeneic Clinical Trial
– Closed Strategic Investment of $43.13 million in the First Four Months of 2016
SHANGHAI, China and CUPERTINO, Calif., May 09, 2016 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group, Inc. (Nasdaq:CBMG) ("CBMG" or the "Company"), a clinical-stage biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported financial results for the first quarter ended March 31, 2016 and provided business highlights.
“In the first quarter of 2016, we made several key clinical and business advancements that we expect will promote long-term growth and strengthen our presence in the cancer and osteoarthritis markets,” commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer. “We reported encouraging Phase IIb data from our most advanced stem cell program for autologous adipose-derived mesenchymal progenitor cell (haMPC) ReJoin® therapy for Knee Osteoarthritis (KOA), and launched a Phase I clinical trial for an off-the-shelf allogeneic haMPC AlloJoinTM therapy for KOA. The closing of a $43.13 million strategic investment through April 2016 brings us closer to reaching our objectives of launching multi-site clinical trials in immuno-oncology cell therapies in China, to file INDs and launch clinical trials for AlloJoinTM therapy for KOA patients in the US and to further strengthen our pipeline. We are determined to build on the momentum from the first quarter and believe that we can accomplish meaningful progress on our 2016 operating objectives.”
First Quarter 2016 Financial Performance
- Cash Position: Cash and cash equivalents as of March 31, 2016 were $15.7 million compared to $14.9 million as of December 31, 2015. We had an increase in cash generated from financing activities due to a private placement financing in February 2016 for gross proceeds of approximately $5 million.
- Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2016 was $3.58 million, compared to $2.41 million for the same period in 2015.
- Revenue: Revenues in the first quarter of 2016 were $488,491 compared to $603,390 for the same period in 2015. The revenue in first quarter 2016 is solely comprised of the hospital’s technology services related to cell therapy treatments.
- G&A Expenses: General and administrative expenses for the first quarter of 2016 were $2.8 million compared to $2.7 million for the same period in 2015.
- R&D Expenses: Research and development expenses for the first quarter of 2016 were $2.40 million, compared to $1.46 million for the same period a year ago. The increase was primarily attributable to the increase of the Company’s immunotherapy research and development team and expenses related to clinical trials.
- Net Loss: Net loss allocable to common stock holders was $4.2 million, compared to $4.3 million for the same period in 2015.
Business & Technology Highlights of 2016 To Date
- Announced encouraging 48-week clinical data from the Phase IIb trial of the Company’s ReJoin® haMPC therapy for Knee Osteoarthritis (KOA), revealing increase of patient’s knee cartilage volume and relief of pain;
- Launched an investigator initiated Phase I clinical trial of an off-the-shelf allogeneic adipose-derived mesenchymal progenitor cell (haMPC) AlloJoinTM therapy for KOA patients in China;
- Advanced the Company’s cash position following the closing of an agreement with Wuhan Dangdai Science & Technology Industries Group Inc. to invest up to $43.13 million for 2.27 million shares of the Company’s common stock, representing a 16.2% post-money stake investment as of April 15, 2016.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our GMP facilities in China, consisting of nine independent cell production lines, are 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 risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. 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. | ||||||||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (UNAUDITED) | ||||||||
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2016 | 2015 | |||||||
| Net sales and revenue | $ | 488,491 | $ | 603,390 | ||||
| Operating expenses: | ||||||||
| Cost of sales | 503,193 | 494,062 | ||||||
| General and administrative | 2,775,925 | 2,680,237 | ||||||
| Selling and marketing | 178,754 | 149,022 | ||||||
| Research and development | 2,398,362 | 1,455,420 | ||||||
| Impairment of investments | - | 123,428 | ||||||
| Total operating expenses | 5,856,234 | 4,902,169 | ||||||
| Operating loss | (5,367,743 | ) | (4,298,779 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 17,050 | 15,111 | ||||||
| Other income (expense) | 16,320 | (2,703 | ) | |||||
| Total other income | 33,370 | 12,408 | ||||||
| Loss before taxes | (5,334,373 | ) | (4,286,371 | ) | ||||
| Income taxes credit (provision) | 1,124,260 | (800 | ) | |||||
| Net loss | $ | (4,210,113 | ) | $ | (4,287,171 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Cumulative translation adjustment | 16,073 | 19,609 | ||||||
| Unrealized gain (loss) on investments, net of tax of $4,514,060 and $nil, for the three months ended March 31, 2016 and 2015, respectively | 16,416,517 | (2,568,271 | ) | |||||
| Total other comprehensive income (loss): | 16,432,590 | (2,548,662 | ) | |||||
| Comprehensive gain (loss) | $ | 12,222,477 | $ | (6,835,833 | ) | |||
| Net loss per share : | ||||||||
| Basic | $ | (0.35 | ) | $ | (0.39 | ) | ||
| Diluted | $ | (0.35 | ) | $ | (0.39 | ) | ||
| Weighted average common shares outstanding: | ||||||||
| Basic | 11,884,066 | 11,039,208 | ||||||
| Diluted | 11,884,066 | 11,039,208 | ||||||
| CELLULAR BIOMEDICINE GROUP, INC. | |||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
| (UNAUDITED) | |||||||||
| March 31, | December 31, | ||||||||
| 2016 | 2015 | ||||||||
| Assets | |||||||||
| Cash and cash equivalents | $ | 15,667,528 | $ | 14,884,597 | |||||
| Accounts receivable | 582,714 | 630,332 | |||||||
| Other receivables | 316,993 | 271,344 | |||||||
| Inventory | 486,348 | 390,886 | |||||||
| Prepaid expenses | 644,250 | 367,050 | |||||||
| Taxes recoverable | - | 150,082 | |||||||
| Total current assets | 17,697,833 | 16,694,291 | |||||||
| Investments | 26,309,984 | 5,379,407 | |||||||
| Property, plant and equipment, net | 2,743,466 | 2,768,900 | |||||||
| Goodwill | 7,678,789 | 7,678,789 | |||||||
| Intangibles, net | 15,511,705 | 15,949,100 | |||||||
| Long-term prepaid expenses and other assets | 1,360,679 | 989,935 | |||||||
| Total assets | $ | 71,302,456 | $ | 49,460,422 | |||||
| Liabilities and Stockholders' Equity | |||||||||
| Liabilities: | |||||||||
| Accounts payable | $ | 208,894 | $ | 260,886 | |||||
| Accrued expenses | 902,265 | 845,087 | |||||||
| Taxes payable | 32,450 | - | |||||||
| Other current liabilities | 2,026,264 | 1,913,284 | |||||||
| Total current liabilities | 3,169,873 | 3,019,257 | |||||||
| Deferred tax liabilities | 3,385,545 | - | |||||||
| Other non-current liabilities | 26,311 | 76,229 | |||||||
| Total liabilities | 6,581,729 | 3,095,486 | |||||||
| Stockholders' equity: | |||||||||
| Preferred stock, par value $.001, 50,000,000 shares | |||||||||
| authorized; none issued and outstanding as of | |||||||||
| March 31, 2016 and December 31, 2015, respectively | - | - | |||||||
| Common stock, par value $.001, 300,000,000 shares authorized; | |||||||||
| 12,001,188 and 11,711,645 issued and outstanding | |||||||||
| as of March 31, 2016 and December 31, 2015, respectively | 12,001 | 11,711 | |||||||
| Additional paid in capital | 109,940,675 | 103,807,651 | |||||||
| Accumulated deficit | (61,548,424 | ) | (57,338,311 | ) | |||||
| Accumulated other comprehensive income (loss) | 16,316,475 | (116,115 | ) | ||||||
| Total stockholders' equity | 64,720,727 | 46,364,936 | |||||||
| Total liabilities and stockholders' equity | $ | 71,302,456 | $ | 49,460,422 | |||||
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2016 | 2015 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (4,210,113 | ) | $ | (4,287,171 | ) | ||
| Adjustments to reconcile net loss to net cash | ||||||||
| used in operating activities: | ||||||||
| Depreciation and amortization | 671,649 | 439,242 | ||||||
| Stock based compensation expense | 1,266,063 | 1,719,458 | ||||||
| Other than temporary impairment on investments | - | 123,428 | ||||||
| Realized losses from sale of investments | - | 5,178 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 50,764 | (198,944 | ) | |||||
| Other receivables | 9,705 | (38,463 | ) | |||||
| Inventory | (96,083 | ) | 94,381 | |||||
| Prepaid expenses | (274,829 | ) | (81,602 | ) | ||||
| Taxes recoverable | 150,082 | - | ||||||
| Other current assets | - | 110,346 | ||||||
| Long-term prepaid expenses and other assets | (38,522 | ) | (44,340 | ) | ||||
| Accounts payable | (51,992 | ) | (266,744 | ) | ||||
| Accrued expenses | 57,178 | 142,276 | ||||||
| Advances payable to related party | - | (30,216 | ) | |||||
| Other current liabilities | 29,415 | 346,585 | ||||||
| Taxes payable | 32,450 | (226,055 | ) | |||||
| Deferred tax liabilities | (1,128,515 | ) | - | |||||
| Other non-current liabilities | (50,049 | ) | (213,254 | ) | ||||
| Net cash used in operating activities | (3,582,797 | ) | (2,405,895 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Proceed from sale of investments, net of issuance cost paid | - | 1,480 | ||||||
| Purchases of intangibles | - | (569,828 | ) | |||||
| Purchases of assets | (674,736 | ) | (179,293 | ) | ||||
| Net cash used in investing activities | (674,736 | ) | (747,641 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of common stock | 4,970,002 | 19,564,846 | ||||||
| Proceeds from exercise of stock options | 93,249 | 26,590 | ||||||
| Repayment of advance from affiliate | - | - | ||||||
| Net cash provided by financing activities | 5,063,251 | 19,591,436 | ||||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH | (22,786 | ) | (63,817 | ) | ||||
| INCREASE IN CASH AND CASH EQUIVALENTS | 782,932 | 16,374,083 | ||||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 14,884,597 | 14,770,584 | ||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 15,667,529 | $ | 31,144,667 | ||||
| SUPPLEMENTAL CASH FLOW INFORMATION | ||||||||
| Cash paid for income taxes | $ | (4,255 | ) | $ | (226,855 | ) | ||