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 - - 787 Accounts receivable, less allowance for doubtful amounts of nil and $94,868 as of December 31, 2019 and December 31, 2018, respectively 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 December 31, 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