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28.02.2020 22:05:00
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Cellular Biomedicine Group Announces Q4 and Full Year 2019 Financial Results and Recent Operational Progress
NEW YORK and SHANGHAI, Feb. 28, 2020 /PRNewswire/ -- Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.
"We made significant progress in 2019 with four cancer immuno-cell therapy ("I/O") clinical studies and our allogeneic off-the-shelf, as well as autologous, stem cell assets on Knee Osteoarthritis ("KOA") clinical trials. We have also embarked on renovating a 22,000 square foot facility in Rockville to expand our research and development ("R&D") footprint in Maryland. Working with our partners, we have made substantial strides in our operation and further institutionalized our Shanghai manufacturing site," said Tony Liu, CEO of the company. "Because of our skills in tech transfer, process development and lean manufacturing, we are emboldened and plan to utilize our four cleanrooms at the Rockville site to support our U.S. clinical studies upon completion of the facility. This month we have also started to collaborate with Shanghai Ruijin Hospital on a pilot clinical study on inhalation of mesenchymal stem cell exosomes treating severe Novel Coronavirus Pneumonia ("NCP"). We are continuing to advance our I/O and KOA drug candidates both in China and the U.S."
Mr. Liu added, "Cell therapy has been embraced by both start-ups and large pharmas with the clear clinical benefits provided to patients globally. CBMG intends to leverage our internal capabilities, namely robust vein-to-vein integrated biopharma capabilities, as well as external collaboration, to rapidly bring these therapies to patients and help cure cancer.
"We are mindful of the ongoing risks posed by the coronavirus disease, or COVID-19. The full extent to which the coronavirus will negatively impact our business operations and results is still highly uncertain and cannot be accurately predicted; however, we have experienced, and expect to continue to experience, a slowdown in patient recruitment for our clinical studies."
2019 Clinical and Business Highlights
- Initiated recruitment and showed early data for our Anti- B-cell maturation antigen ("BCMA") Chimeric antigen receptor T-cells ("CAR-T") for relapsed or refractory Multiple Myeloma ("r/r MM")
- Began patient enrollment for our CD19/CD20 BiCar for Non-Hodgkins Lymphoma ("NHL")
- Dosed first patient for our Alpha-Fetoprotein T-Cell Receptor ("AFP-TCR-T") technology targeting Hepatocellular Carcinoma ("HCC")
- Began dosing patients for our Anti-CD20 CAR-T, targeting Anti-CD19 treated, relapsed Diffuse Large B-Cell Lymphoma ("DLBCL")
- Received China National Medical Products Administration ("NMPA") Investigational New Drug application ("IND") acceptance to move to Phase II clinical trial for both off-the-shelf AlloJoin® and ReJoin® human adipose-derived mesenchymal progenitor cell ("haMPC") therapies for KOA
- Expanding US footprint with new facility in Rockville, Maryland to support R&D and clinical studies
Fourth Quarter and Full Year 2019 Financial Results
- Cash Position: Cash, cash equivalents and restricted cash as of December 31, 2019 were $32.4 million, compared to $52.8 million as of December 31, 2018
- R&D Expenses: Research and development expenses were $37.7 million for 2019 as compared to $24.2 million for 2018
- G&A Expenses: General and administrative expenses were $13.5 million for 2019 as compared to $13.2 million for 2018
- Net Loss: Net loss was $50 million for 2019 as compared to $38.9 million for 2018
About Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group, Inc. is a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases. For more information, please visit https://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. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those currently anticipated, including, but not limited to, the risks of failure inherent in the development of products based on new biomedical technologies as well as the other risks detailed from time to time in CBMG's reports filed with the Securities and Exchange Commission, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-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, we 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. | |||||
CONSOLIDATED BALANCE SHEETS | |||||
December 31, | December 31, | ||||
2019 | 2018 | ||||
Assets | |||||
Cash and cash equivalents | $ 15,443,649 | $ 52,812,880 | |||
Restricted cash | 17,000,000 | - | |||
Accounts receivable, less allowance for doubtful amounts of nil and $94,868 as of December 31, 2019 and December 31, 2018, respectively | - | 787 | |||
Other receivables | 750,943 | 101,909 | |||
Prepaid expenses | 835,048 | 1,692,135 | |||
Total current assets | 34,029,640 | 54,607,711 | |||
Investments | 240,000 | 240,000 | |||
Property, plant and equipment, net | 21,434,414 | 15,193,761 | |||
Right of use | 20,106,163 | 15,938,203 | |||
Goodwill | 7,678,789 | 7,678,789 | |||
Intangibles, net | 7,376,940 | 7,970,692 | |||
Long-term prepaid expenses and other assets | 6,458,354 | 5,952,193 | |||
Total assets | $ 97,324,300 | $ 107,581,349 | |||
Liabilities and Stockholders' Equity | |||||
Liabilities: | |||||
Short-term debt | $ 14,334,398 | $ - | |||
Accounts payable | 2,039,686 | 422,752 | |||
Accrued expenses | 1,904,829 | 1,878,926 | |||
Taxes payable | 26,245 | 28,950 | |||
Other current liabilities | 5,367,708 | 5,710,578 | |||
Total current liabilities | 23,672,866 | 8,041,206 | |||
Other non-current liabilities | 17,933,743 | 14,321,751 | |||
Total liabilities | 41,606,609 | 22,362,957 | |||
Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of December 31, 2019 and 2018, respectively | - | - | |||
Common stock, par value $.001, 300,000,000 shares authorized; 20,359,889 and 19,120,781 issued; and 19,304,390 and 18,119,282 outstanding, as of December 31, 2019 and 2018, respectively | 20,360 | 19,121 | |||
Treasury stock at cost; 1,055,499 and 1,001,499 shares of common stock | (14,992,694) | (13,953,666) | |||
as of December 31, 2019 and December 31, 2018, respectively | |||||
Additional paid in capital | 272,117,518 | 250,604,618 | |||
Accumulated deficit | (199,966,543) | (149,982,489) | |||
Accumulated other comprehensive loss | (1,460,950) | (1,469,192) | |||
Total stockholders' equity | 55,717,691 | 85,218,392 | |||
Total liabilities and stockholders' equity | $ 97,324,300 | $ 107,581,349 | |||
CELLULAR BIOMEDICINE GROUP, INC. | |||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
For the Year Ended | |||||||
December 31, | |||||||
2019 | 2018 | 2017 | |||||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
Net loss | $ (49,984,054) | $ (38,945,492) | $ (25,490,310) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 5,638,303 | 5,049,523 | 2,985,963 | ||||
Loss on disposal of assets | 39,033 | 4,957 | 317 | ||||
Stock based compensation expense | 4,063,981 | 4,826,745 | 5,345,211 | ||||
Other than temporary impairment on investments | - | 29,424 | - | ||||
Impairment on intangible assets | - | 2,884,896 | - | ||||
Interest income from six-month deposits with the banks | - | (175,479) | - | ||||
Interest income from pledged bank deposits | (500,219) | - | - | ||||
Interest expenses | 481,895 | - | - | ||||
Allowance for doubtful account | - | 84,622 | - | ||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | 774 | 107,263 | (160,628) | ||||
Other receivables | (150,222) | 66,108 | (467,985) | ||||
Prepaid expenses | 831,686 | 68,435 | (812,675) | ||||
Long-term prepaid expenses and other assets | (1,324,924) | (538,349) | (1,005,029) | ||||
Accounts payable | 1,170,688 | 133,740 | (814) | ||||
Accrued expenses | 48,762 | 816,936 | (118,968) | ||||
Other current liabilities | (43,401) | 390,181 | 1,339,866 | ||||
Taxes payable | (2,705) | 75 | - | ||||
Other non-current liabilities | 80,420 | 83,416 | (208,340) | ||||
Net cash used in operating activities | (39,649,983) | (25,112,999) | (18,593,392) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
Proceeds from disposal of assets | 148,393 | 1,625 | - | ||||
Withdrawing six-month deposits with the banks | - | 10,175,479 | - | ||||
Putting six-month deposits with the banks | - | (10,000,000) | - | ||||
Purchases of intangible assets | (869,110) | (196,836) | (23,734) | ||||
Purchases of property, plant and equipment | (10,674,812) | (6,589,493) | (10,169,134) | ||||
Net cash used in investing activities | (11,395,529) | (6,609,225) | (10,192,868) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
Net proceeds from the issuance of common stock | 17,166,199 | 70,351,173 | 14,496,040 | ||||
Proceeds from exercise of stock options | 283,959 | 2,738,866 | 308,371 | ||||
Proceeds from short-term debt | 14,546,035 | - | - | ||||
Interest paid | (470,901) | - | - | ||||
Repurchase of treasury stock | (1,039,028) | (9,975,737) | (3,977,929) | ||||
Net cash provided by financing activities | 30,486,264 | 63,114,302 | 10,826,482 | ||||
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 190,017 | (147,620) | 275,768 | ||||
INCREASE/(DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (20,369,231) | 31,244,458 | (17,684,010) | ||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 52,812,880 | 21,568,422 | 39,252,432 | ||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | $ 32,443,649 | $ 52,812,880 | $ 21,568,422 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION | |||||||
Cash paid for income taxes | $ 3,750 | $ 4,879 | $ 2,450 | ||||
December 31, | December 31, | December 31, | |||||
2019 | 2018 | 2017 | |||||
Reconciliation of cash, cash equivalents and restricted cash in condensed consolidated statements of cash flows: | |||||||
Restricted cash | $ 17,000,000 | $ - | $ - | ||||
Cash and cash equivalents | 15,443,649 | 52,812,880 | 21,568,422 | ||||
Cash, cash equivalents and restricted cash | $ 32,443,649 | $ 52,812,880 | $ 21,568,422 | ||||
CELLULAR BIOMEDICINE GROUP, INC. | ||||||||||
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||
For the Year Ended | ||||||||||
2019 | 2018 | 2017 | ||||||||
Net sales and revenue | $ 339,920 | $ 224,403 | $ 336,817 | |||||||
Operating expenses: | ||||||||||
Cost of sales | 62,378 | 135,761 | 162,218 | |||||||
General and administrative | 13,458,151 | 13,220,757 | 12,780,483 | |||||||
Selling and marketing | 141,597 | 308,830 | 360,766 | |||||||
Research and development | 37,669,978 | 24,150,480 | 14,609,917 | |||||||
Impairment of non-current assets | - | 2,914,320 | - | |||||||
Total operating expenses | 51,332,104 | 40,730,148 | 27,913,384 | |||||||
Operating loss | (50,992,184) | (40,505,745) | (27,576,567) | |||||||
Other income: | ||||||||||
Interest income | 809,785 | 392,328 | 133,621 | |||||||
Other income | 199,390 | 1,172,879 | 1,955,086 | |||||||
Total other income | 1,009,175 | 1,565,207 | 2,088,707 | |||||||
Loss before taxes | (49,983,009) | (38,940,538) | (25,487,860) | |||||||
Income taxes provision | (1,045) | (4,954) | (2,450) | |||||||
Net loss | $ (49,984,054) | $ (38,945,492) | $ (25,490,310) | |||||||
Other comprehensive income (loss): | ||||||||||
Cumulative translation adjustment | 8,242 | (1,079,689) | 967,189 | |||||||
Unrealized loss on investments, net of tax | - | - | (240,000) | |||||||
Total other comprehensive income (loss): | 8,242 | (1,079,689) | 727,189 | |||||||
Comprehensive loss | $ (49,975,812) | $ (40,025,181) | $ (24,763,121) | |||||||
Net loss per share: | ||||||||||
Basic and diluted | $ (2.63) | $ (2.20) | $ (1.78) | |||||||
Weighted average common shares outstanding: | ||||||||||
Basic and diluted | 18,983,206 | 17,741,104 | 14,345,604 | |||||||
For more information, please contact:
Company Contact:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: derrick.li@cellbiomedgroup.com
Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: cellbiomed@kcsa.com
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SOURCE Cellular Biomedicine Group
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