- China Food and Drug Administration Accepts the Company’s Investigational New Drug (IND) Applications for anti-CD19 CAR-T Therapy Targeting NHL and ALL
- Positive 48-Week Phase I Clinical Data of AlloJoinTM haMPC therapy for KOA in China
- Ended quarter with $45.6 million in Cash
SHANGHAI, China and CUPERTINO, Calif., May 08, 2018 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported financial results and business highlights for the first quarter ended March 31, 2018.
“Early in 2018, we’ve made notable progress with our immuno-oncology platform as the China Food and Drug Administration (CFDA) accepted the Company’s Investigational New Drug Applications (IND) for “C-CAR011” anti-CD19 chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with B-cell Non-Hodgkin’s lymphoma (NHL) and acute lymphoblastic leukemia (ALL),” commented Tony Liu, Chief Executive Officer of CBMG. “We are advancing recognized CAR-T therapies through China’s regulatory pathway, with our state of the art GMP facility, which houses a CBMG-GE Healthcare China joint innovation center, and a CBMG-Thermo Fisher Scientific joint innovation center.
“The recent investment from Sailing Capital Overseas Investment Ltd., of $30.6 million, will enable further clinical development by funding our current multiple clinical programs, as well as expanding our immuno-oncology pipeline with further CAR-T receptor constructs for various liquid and solid tumor indications, including, but not limited to, Anti-BCMA CAR for multiple myeloma (MM). We continue to focus on accelerating deployment of new cell therapies to the clinical stage, confident in our in-house research and development capabilities, our CMC platform, and our broad clinical development network with leading medical institutions in China.”
Business & Technology Highlights of 2018 To Date
- SUBMITTED IND APPLICATION TO CFDA: In April 2018, the CFDA accepted the IND applications for “C-CAR011” anti-CD19 CAR-T therapy targeting NHL and ALL;
- PUBLISHED KOA DATA: In March 2018, 48-week clinical data from the Phase I clinical trial in China was presented for its allogeneic adipose-derived mesenchymal progenitor cell off-the-shelf therapy AlloJoinTM for Knee Osteoarthritis (KOA), which demonstrated good safety and early efficacy for the prevention of cartilage deterioration;
- ENTERED INTO AGREEMENT WITH MEDICAL COLLEGE OF GEORGIA, AUGUSTA UNIVERSITY: In February 2018, CBMG, through its wholly-owned subsidiary, entered into an agreement with Augusta University to take a three-year option to license technology for T Cell Receptor (TCR), targeting Hepatocellular Carcinoma (HCC) (patent pending);
- COMPLETED PRIVATE EQUITY FINANCING: In February 2018, CBMG received a $30.6 million investment from Sailing Capital, a global private equity firm focused on disruptive technologies from innovative global companies in the healthcare, technology and consumer sectors;
- EXPANDED AGREEMENT WITH GE HEALTHCARE CHINA: In January 2018, CBMG and GE HEALTHCARE signed a plan to make CBMG the first company in the world to install GE HEALTHCARE FlexFactoryTM for cell therapy. CBMG will configure part of its facility in Shanghai with GE Healthcare’s FlexFactory™ platform to accelerate manufacturing timelines for its cell therapy clinical trials and commercial launches.
First Quarter 2018 Financial Performance
- Cash Position: Cash and cash equivalents as of March 31, 2018 were $45.6 million compared to $21.6 million as of December 31, 2017;
- Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2018 was $5.6 million, compared to $4.9 million for the same period in 2017;
- G&A Expenses: General and administrative expenses for the first quarter of 2018 were $3.2 million compared to $3.2 million for the same period in 2017;
- R&D Expenses: Research and development expenses for the first quarter of 2018 were $5.3 million, compared to $3.0 million for the same period a year ago. The increase was primarily due to the pick-up in the Company's development work and new talents recruited for anti-BCMA target for multiple myeloma, and other solid tumor indications at the Company’s newly operating state of the art GMP facility;
- Net Loss: Net loss allocable to common stock holders was $8.5 million, compared to $6.2 million for the same period in 2017.
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (UNAUDITED) | ||||||||
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2018 | 2017 | |||||||
| Net sales and revenue | $ | 50,961 | $ | 98,425 | ||||
| Operating expenses: | ||||||||
| Cost of sales | 22,300 | 37,402 | ||||||
| General and administrative | 3,188,797 | 3,185,247 | ||||||
| Selling and marketing | 74,585 | 117,884 | ||||||
| Research and development | 5,273,951 | 3,044,125 | ||||||
| Total operating expenses | 8,559,633 | 6,384,658 | ||||||
| Operating loss | (8,508,672 | ) | (6,286,233 | ) | ||||
| Other income | ||||||||
| Interest income | 5,449 | 49,182 | ||||||
| Other income | 9,200 | 77,508 | ||||||
| Total other income | 14,649 | 126,690 | ||||||
| Loss before taxes | (8,494,023 | ) | (6,159,543 | ) | ||||
| Income taxes provision | (2,400 | ) | (2,450 | ) | ||||
| Net loss | $ | (8,496,423 | ) | $ | (6,161,993 | ) | ||
| Other comprehensive income: | ||||||||
| Cumulative translation adjustment | 818,361 | 53,669 | ||||||
| Total other comprehensive income: | 818,361 | 53,669 | ||||||
| Comprehensive loss | $ | (7,678,062 | ) | $ | (6,108,324 | ) | ||
| Net loss per share : | ||||||||
| Basic | $ | (0.51 | ) | $ | (0.43 | ) | ||
| Diluted | $ | (0.51 | ) | $ | (0.43 | ) | ||
| Weighted average common shares outstanding: | ||||||||
| Basic | 16,742,591 | 14,281,745 | ||||||
| Diluted | 16,742,591 | 14,281,745 | ||||||
| CELLULAR BIOMEDICINE GROUP, INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (UNAUDITED) | |||||||
| March 31, | December 31, | ||||||
| 2018 | 2017 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 45,555,891 | $ | 21,568,422 | |||
| Accounts receivable, less allowance for doubtful accounts of $11,212 | |||||||
| and $10,789 as of March 31, 2018 and December 31, 2017, respectively | 128,879 | 202,887 | |||||
| Other receivables | 937,447 | 902,940 | |||||
| Prepaid expenses | 2,033,836 | 1,852,695 | |||||
| Total current assets | 48,656,053 | 24,526,944 | |||||
| Investments | 269,424 | 269,424 | |||||
| Property, plant and equipment, net | 14,600,398 | 12,973,342 | |||||
| Goodwill | 7,678,789 | 7,678,789 | |||||
| Intangibles, net | 12,029,782 | 12,419,692 | |||||
| Long-term prepaid expenses and other assets | 3,491,710 | 3,294,105 | |||||
| Total assets | $ | 86,726,156 | $ | 61,162,296 | |||
| Liabilities and Stockholders' Equity | |||||||
| Liabilities: | |||||||
| Accounts payable | $ | 331,753 | $ | 225,287 | |||
| Accrued expenses | 1,855,508 | 1,097,327 | |||||
| Taxes payable | 31,275 | 28,875 | |||||
| Other current liabilities | 2,986,701 | 2,324,632 | |||||
| Total current liabilities | 5,205,237 | 3,676,121 | |||||
| Other non-current liabilities | 198,849 | 183,649 | |||||
| Total liabilities | 5,404,086 | 3,859,770 | |||||
| Stockholders' equity: | |||||||
| Preferred stock, par value $.001, 50,000,000 shares | |||||||
| authorized; none issued and outstanding as of | |||||||
| March 31, 2018 and December 31, 2017, respectively | - | - | |||||
| Common stock, par value $.001, 300,000,000 shares authorized; | |||||||
| 17,453,623 and 15,615,558 issued; and 16,989,367 and 15,188,764 outstanding, | |||||||
| as of March 31, 2018 and December 31, 2017, respectively | 17,454 | 15,616 | |||||
| Treasury stock at cost; 464,256 and 426,794 shares of common stock | |||||||
| as of March 31, 2018 and December 31, 2017, respectively | (4,693,597 | ) | (3,977,929 | ) | |||
| Additional paid in capital | 205,102,775 | 172,691,339 | |||||
| Accumulated deficit | (119,533,420 | ) | (111,036,997 | ) | |||
| Accumulated other comprehensive loss | 428,858 | (389,503 | ) | ||||
| Total stockholders' equity | 81,322,070 | 57,302,526 | |||||
| Total liabilities and stockholders' equity | $ | 86,726,156 | $ | 61,162,296 | |||
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2018 | 2017 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (8,496,423 | ) | $ | (6,161,993 | ) | ||
| Adjustments to reconcile net loss to net cash | ||||||||
| used in operating activities: | ||||||||
| Depreciation and amortization | 1,175,488 | 669,739 | ||||||
| Loss on disposal of assets | 935 | 237 | ||||||
| Stock based compensation expense | 1,134,881 | 1,431,907 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 81,633 | (39,411 | ) | |||||
| Other receivables | (4,820 | ) | (398,190 | ) | ||||
| Prepaid expenses | (112,228 | ) | (78,832 | ) | ||||
| Long-term prepaid expenses and other assets | (436,503 | ) | 6,524 | |||||
| Accounts payable | 26,596 | 565,236 | ||||||
| Accrued expenses | 731,748 | (844,172 | ) | |||||
| Other current liabilities | 276,230 | (2,012 | ) | |||||
| Taxes payable | 2,400 | 2,450 | ||||||
| Other non-current liabilities | 8,012 | (10,146 | ) | |||||
| Net cash used in operating activities | (5,612,051 | ) | (4,858,663 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchases of intangibles | - | (23,268 | ) | |||||
| Purchases of property, plant and equipment | (1,082,635 | ) | (1,026,994 | ) | ||||
| Net cash used in investing activities | (1,082,635 | ) | (1,050,262 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of common stock | 30,508,670 | - | ||||||
| Proceeds from exercise of stock options | 769,723 | 5,514 | ||||||
| Repurchase of treasury stock | (715,668 | ) | - | |||||
| Net cash provided by financing activities | 30,562,725 | 5,514 | ||||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH | 119,430 | 12,763 | ||||||
| INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 23,987,469 | (5,890,648 | ) | |||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 21,568,422 | 39,252,432 | ||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 45,555,891 | $ | 33,361,784 | ||||
| SUPPLEMENTAL CASH FLOW INFORMATION | ||||||||
| Cash paid for income taxes | $ | - | $ | - | ||||
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Our Shanghai facility includes a ”Joint Laboratory of Cell Therapy” with GE Healthcare and a “Joint Cell Therapy Technology Innovation and Application Center” with Thermo Fisher Scientific, which partnerships focus on improving manufacturing processes for cell therapies. CBMG currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL) and CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), utilizing CBMG’s proprietary and optimized CD19 construct, a Phase IIb trial in China for Rejoin® autologous Human Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee Osteoarthritis (KOA) as well as a Phase I trial in China for AlloJoin™ (CBMG’s “Off-the-Shelf” haMPC) for the treatment of KOA. In Q1 2018 CBMG was added to the Loncar China BioPharma index. 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 and 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 those regarding our ability to implement our plans, strategies and objectives for future operations, including our plan to configure part of our Shanghai facility with GE Healthcare’s FlexFactory platform, our ability to execute on proposed new products, services or development thereof, results of our clinical research and development, regulatory infrastructure governing cell therapy and cellular biopharmaceuticals, our ability to enter into agreements with any necessary manufacturing, marketing and/or distribution partners for purposes of commercialization, our ability to seek intellectual property rights for our product candidates, competition in the industry in which we operate, overall market conditions, any statements or assumptions underlying any of the foregoing 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.
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com