Cellular Biomedicine Group Reports Second Quarter and First Half 2018 Financial Results and Business Highlights
SHANGHAI, China and CUPERTINO, Calif., Aug. 08, 2018 (GLOBE NEWSWIRE) --
- China Food and Drug Administration (CFDA) Accepts the Company’s Investigational New Drug (IND) Applications for anti-CD19 CAR-T Therapy Targeting NHL and ALL
- Moved to New R&D Center in Gaithersburg, Maryland, USA
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 second quarter and six months ended June 30, 2018.
“The acceptance of CBMG’s IND application 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) reinforces the strength of our immuno-oncology platform. We look forward to working with the CFDA to obtain approval to move to the next phase of development,” commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG. “We continue to deploy our working capital to pursue and develop a robust non-CD19 pipeline targeting other liquid and solid tumors. We are also advancing our quality systems and automated manufacturing capabilities by utilizing digital technologies with the goal of becoming a premier international biopharma company and a preferred collaborator for cell therapy development in China. With the expansion and relocation of our U.S. R&D center to Gaithersburg, Maryland, we are committed to leverage our talented team to develop the latest technology in cancer cell therapy. Being in the heart of this renowned research hub presents us with opportunities to collaborate with leading experts in this ecosystem to bridge new therapies developed in the U.S. into our clinical development in China, ultimately leading to serve the China market.”
Second Quarter and First Half 2018 Financial Performance
- G&A Expenses: General and administrative expenses remain relatively flat for the six months ended June 30, 2018 compared to the same period in 2017 due to the efficient management and utilization of resources. General and administrative expenses for the quarter and six months ended June 30, 2018 were $3.1 million and $6.3 million, respectively, compared to $3.3 million and $6.4 million for the same periods in 2017.
- R&D Expenses: Research and development expenses grew substantially for the six months ended June 30, 2018 compared to the same period in 2017 due to the expanded commitment to research and development, process improvement and anticipated clinical activities. Research and development expenses for the quarter and six months ended June 30, 2018 were $6.2 million and $11.4 million respectively, compared to $3.3 million and $6.4 million for the same periods in 2017.
- Net Loss: Net loss allocable to common stock holders for the quarter and six months ended June 30, 2018 was $9.2 million and $17.7 million respectively, compared to $6.2 million and $12.4 million for the same periods in 2017.
Business & Technology Highlights First Half 2018
- MOVED TO NEW R&D CENTER IN GAITHERSBURG: In May 2018, the Company moved its Maryland lab to a larger research and development center in Gaithersburg to accelerate the Company’s robust oncology research pipeline, to attract new recruits and to work closely with potential collaborating partners;
- SUBMITTED IND APPLICATIONS TO CFDA: In April 2018, the CFDA accepted the IND applications for anti-CD19 CAR-T therapy “C-CAR011” targeting NHL and ALL and the Company is working with the CFDA for approval to move to the next phase of development;
- PUBLISHED KOA DATA: In March 2018, the Company presented its allogeneic adipose-derived mesenchymal progenitor cell off-the-shelf therapy AlloJoinTM for Knee Osteoarthritis (KOA) 48-week clinical data from the Phase I clinical trial in China, which demonstrated good safety and early efficacy for the prevention of cartilage deterioration;
- OBTAINED OPTION TO LICENSE PATENT ON AFP TCR-T for HEPATOCELLULAR CARCINOMA: In February 2018, CBMG’s wholly-owned subsidiary entered into an agreement with Augusta University to take a three-year option to license technology for Alpha fetoprotein (AFP) T Cell Receptor (TCR), targeting Hepatocellular Carcinoma (HCC) (patent pending);
- COMPLETED PRIVATE EQUITY FINANCING: In February 2018, Sailing Capital invested $30.6 million in CBMG. Sailing Capital is a global private equity firm focused on disruptive technologies from innovative global companies in the healthcare, technology and consumer sectors.
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. CBMG is included in the broad-market Russell 3000® Index and the small-cap Russell 2000® Index, and 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 regulatory approval of our IND applications, 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.
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| For the Six Months Ended | ||||||||
| June 30, | ||||||||
| 2018 | 2017 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (17,682,499 | ) | $ | (12,365,511 | ) | ||
| Adjustments to reconcile net loss to net cash | ||||||||
| used in operating activities: | ||||||||
| Depreciation and amortization | 2,486,145 | 1,369,168 | ||||||
| Loss / (gain) on disposal of assets | 2,721 | (49 | ) | |||||
| Stock based compensation expense | 2,477,614 | 2,902,113 | ||||||
| Other than temporary impairment on long-term investments | 29,424 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 66,451 | (50,557 | ) | |||||
| Other receivables | 20,006 | (488,480 | ) | |||||
| Prepaid expenses | (579,479 | ) | 13,246 | |||||
| Long-term prepaid expenses and other assets | (649,262 | ) | (237,637 | ) | ||||
| Accounts payable | 114,249 | 949,142 | ||||||
| Accrued expenses | (9,892 | ) | (595,382 | ) | ||||
| Deferred income | (4,515 | ) | 1,069,515 | |||||
| Other current liabilities | 166,870 | 35,542 | ||||||
| Other non-current liabilities | (93,732 | ) | (379,161 | ) | ||||
| Net cash used in operating activities | (13,655,899 | ) | (7,778,051 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Proceeds from disposal of assets | - | 286 | ||||||
| Putting six-month deposits with the banks | (10,000,000 | ) | - | |||||
| Purchases of intangibles | (34,172 | ) | (23,339 | ) | ||||
| Purchases of assets | (2,167,527 | ) | (3,014,055 | ) | ||||
| Net cash used in investing activities | (12,201,699 | ) | (3,037,108 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of common stock | 30,506,521 | - | ||||||
| Proceeds from exercise of stock options | 1,165,763 | 73,779 | ||||||
| Repurchase of treasury stock | (2,536,064 | ) | (1,357,931 | ) | ||||
| Net cash provided by financing activities | 29,136,220 | (1,284,152 | ) | |||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH | (61,177 | ) | 145,324 | |||||
| INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS | 3,217,445 | (11,953,987 | ) | |||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 21,568,422 | 39,252,432 | ||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 24,785,867 | $ | 27,298,445 | ||||
| CELLULAR BIOMEDICINE GROUP, INC. |
||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||||||
| (UNAUDITED) |
||||||||||||||||
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Net sales and revenue | $ | 77,313 | $ | 62,914 | $ | 128,274 | $ | 161,339 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 54,393 | 38,097 | 76,693 | 75,499 | ||||||||||||
| General and administrative | 3,121,695 | 3,319,093 | 6,310,492 | 6,504,340 | ||||||||||||
| Selling and marketing | 92,880 | 76,385 | 167,465 | 194,269 | ||||||||||||
| Research and development | 6,166,556 | 3,349,509 | 11,440,507 | 6,393,634 | ||||||||||||
| Impairment of long-term investments | 29,424 | - | 29,424 | - | ||||||||||||
| Total operating expenses | 9,464,948 | 6,783,084 | 18,024,581 | 13,167,742 | ||||||||||||
| Operating loss | (9,387,635 | ) | (6,720,170 | ) | (17,896,307 | ) | (13,006,403 | ) | ||||||||
| Other income : | ||||||||||||||||
| Interest income | 116,835 | 40,573 | 122,284 | 89,755 | ||||||||||||
| Other income | 84,724 | 476,079 | 93,924 | 553,587 | ||||||||||||
| Total other income | 201,559 | 516,652 | 216,208 | 643,342 | ||||||||||||
| Loss before taxes | (9,186,076 | ) | (6,203,518 | ) | (17,680,099 | ) | (12,363,061 | ) | ||||||||
| Income taxes provision | - | - | (2,400 | ) | (2,450 | ) | ||||||||||
| Net loss | $ | (9,186,076 | ) | $ | (6,203,518 | ) | $ | (17,682,499 | ) | $ | (12,365,511 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Cumulative translation adjustment | (1,120,722 | ) | 292,452 | (302,361 | ) | 346,121 | ||||||||||
| Unrealized loss on investments, net of tax | - | (240,000 | ) | - | (240,000 | ) | ||||||||||
| Total other comprehensive income (loss): | (1,120,722 | ) | 52,452 | (302,361 | ) | 106,121 | ||||||||||
| Comprehensive loss | $ | (10,306,798 | ) | $ | (6,151,066 | ) | $ | (17,984,860 | ) | $ | (12,259,390 | ) | ||||
| Net loss per share : | ||||||||||||||||
| Basic and diluted | $ | (0.53 | ) | $ | (0.43 | ) | $ | (1.03 | ) | $ | (0.87 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 17,487,184 | 14,298,973 | 17,116,944 | 14,211,888 | ||||||||||||
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (UNAUDITED) | ||||||||
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 24,785,867 | $ | 21,568,422 | ||||
| Short-term investment | 10,000,000 | - | ||||||
| Accounts receivable, less allowance for doubtful amounts of $10,655 | ||||||||
| and $10,789 as of June 30, 2018 and December 31, 2017, respectively | 133,876 | 202,887 | ||||||
| Other receivables | 150,128 | 170,842 | ||||||
| Prepaid expenses | 2,409,101 | 1,852,695 | ||||||
| Total current assets | 37,478,972 | 23,794,846 | ||||||
| Long-term investments | 240,000 | 269,424 | ||||||
| Property, plant and equipment, net | 14,072,278 | 12,973,342 | ||||||
| Goodwill | 7,678,789 | 7,678,789 | ||||||
| Intangibles, net | 11,538,905 | 12,419,692 | ||||||
| Long-term prepaid expenses and other assets | 4,805,996 | 4,026,203 | ||||||
| Total assets | $ | 75,814,940 | $ | 61,162,296 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Liabilities: | ||||||||
| Accounts payable | $ | 387,860 | $ | 225,287 | ||||
| Accrued expenses | 1,078,584 | 1,097,327 | ||||||
| Taxes payable | 28,875 | 28,875 | ||||||
| Other current liabilities | 3,300,520 | 2,324,632 | ||||||
| Total current liabilities | 4,795,839 | 3,676,121 | ||||||
| Other non-current liabilities | 87,601 | 183,649 | ||||||
| Total liabilities | 4,883,440 | 3,859,770 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, par value $.001, 50,000,000 shares | ||||||||
| authorized; none issued and outstanding as of | ||||||||
| June 30, 2018 and December 31, 2017, respectively | - | - | ||||||
| Common stock, par value $.001, 300,000,000 shares authorized; | ||||||||
| 17,503,238 and 15,615,558 issued; and 16,942,470 and 15,188,764 outstanding, | ||||||||
| as of June 30, 2018 and December 31, 2017, respectively | 17,503 | 15,616 | ||||||
| Treasury stock at cost: 560,768 and 426,794 shares of common stock | ||||||||
| as of June 30, 2018 and December 31, 2017, respectively | (6,513,993 | ) | (3,977,929 | ) | ||||
| Additional paid in capital | 206,839,350 | 172,691,339 | ||||||
| Accumulated deficit | (128,719,496 | ) | (111,036,997 | ) | ||||
| Accumulated other comprehensive loss | (691,864 | ) | (389,503 | ) | ||||
| Total stockholders' equity | 70,931,500 | 57,302,526 | ||||||
| Total liabilities and stockholders' equity | $ | 75,814,940 | $ | 61,162,296 | ||||
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/f9b2bd6d-579b-4b5a-8b0c-4c2a3794d6c0