Cellular Biomedicine Group Reports First Quarter 2019 Results and Highlights Operational Progress
-- Initiated patient recruitment for Phase I trial of anti-BCMA CAR-T therapy targeting relapsed and refractory Multiple Myeloma in China
-- AlloJoin® therapy for Knee Osteoarthritis (KOA) approved as first stem cell KOA drug application in China for a Phase II clinical trial
-- Ended quarter with $62 million in cash
NEW YORK and SHANGHAI, April 30, 2019 /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 its financial results and business highlights for the first quarter ended March 31, 2019.
"Early in 2019, we achieved the first of many milestones anticipated for this year in support of our immuno-oncology platform, as we initiated patient recruitment for our Phase I trial of anti-BCMA CAR-T therapy targeting multiple myeloma in China. We are also on track with the technology transfer from the strategic licensing and collaboration agreement that we signed during the 2018 third quarter with a global leader in CAR-T cell therapy for patients in China," commented Tony Liu, Chief Executive Officer of CBMG. "In addition to the AFP-TCR and TIL solid tumor platform, in 2019 we plan to initiate clinical development for CAR-T programs for CD22, CD20 and NKG2D for hematological cancers, and AFP TCR-T for metastatic HCC. Also during the first quarter, significant progress was made with our Stem Cell Platform as our IND application for AlloJoin® for KOA became the first stem cell drug application to be approved by China's CDE for a Phase II KOA clinical trial since the new Regulation's release*. Our broad clinical development programs and investments into our in-house research, manufacturing capabilities and our CMC platform remain a key part of our strategy to realize the potential of CAR-T cell therapies for patients suffering from various cancers."
* China NMPA (formerly CFDA) clarified Cell Therapy Regulations in December 2017 (the "Regulation") whereby all cell therapies are being treated as drug NDA/IND.
First Quarter 2019 Financial Performance
- Cash Position: Cash position as of March 31, 2019 was $62 million (including restricted cash) compared to $52.8 million as of December 31, 2018;
- Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2019 was $7.9 million, compared to $5.6 million for the same period in 2018, a 41% increase;
- G&A Expenses: General and administrative expenses for the first quarter of 2019 were $3.4 million compared to $3.2 million for the same period in 2018, an 8% increase;
- R&D Expenses: Research and development expenses for the first quarter of 2019 were $6.0 million, compared to $5.3 million for the same period a year ago, a 13% increase. The increase was primarily due the increased spending in the growth of our pipeline in both liquid tumor and solid tumor development;
- Net Loss: Net loss allocable to common stock holders was $9.3 million, compared to $8.5 million for the same period in 2018, a 10% increase.
- In January 2019, China Merchants Bank granted the Company a credit up to RMB 100 million (approximately $14.7 million) via revolving and/or one-time credit lines, which period runs until December 30, 2019. As of March 31, 2019, $6.1 million had been drawn down under this banking facility.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on Wednesday, May 1st at 8:30 a.m. Eastern Time / 8:30 p.m. China Standard Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.
Live Call: | Toll-Free: 1-877-423-9813 International: 1-201-689-8573 |
Webcast: | |
Replay: | Toll-Free: 1-844-512-2921 International: 1-412-317-6671 Conference ID: 13690103 (Available approximately two hours after the completion of the live call until 11:59 p.m. ET on May 15, 2019) |
About Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. It conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. Its GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to both China and U.S. GMP standards.
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 our obligations under the terms of our licensing and collaboration arrangement with Novartis, 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, it 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.
For more information, please contact:
Company Contact:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: [email protected]
Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: [email protected]
CELLULAR BIOMEDICINE GROUP, INC. | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(UNAUDITED) | |||||||
March 31, | December 31, | ||||||
2019 | 2018 | ||||||
Assets | |||||||
Cash and cash equivalents | $45,037,517 | $52,812,880 | |||||
Restricted cash | 17,000,000 | $- | |||||
Accounts receivable, less allowance for doubtful accounts of nil and $94,868 as of March 31, 2019 and December 31, 2018, respectively | - | 787 | |||||
Other receivables | 263,158 | 101,909 | |||||
Prepaid expenses | 2,733,614 | 1,692,135 | |||||
Total current assets | 65,034,289 | 54,607,711 | |||||
Investments | 240,000 | 240,000 | |||||
Property, plant and equipment, net | 15,157,707 | 15,193,761 | |||||
Right of use | 16,017,978 | 15,938,203 | |||||
Goodwill | 7,678,789 | 7,678,789 | |||||
Intangibles, net | 8,259,257 | 7,970,692 | |||||
Long-term prepaid expenses and other assets | 8,951,077 | 5,952,193 | |||||
Total assets | $121,339,097 | $107,581,349 | |||||
Liabilities and Stockholders' Equity | |||||||
Liabilities: | |||||||
Short-term debt | $6,131,723 | $- | |||||
Accounts payable | 868,590 | 422,752 | |||||
Accrued expenses | 1,894,470 | 1,878,926 | |||||
Taxes payable | 28,950 | 28,950 | |||||
Other current liabilities | 5,762,778 | 5,710,578 | |||||
Total current liabilities | 14,686,511 | 8,041,206 | |||||
Other non-current liabilities | 14,141,557 | 14,321,751 | |||||
Total liabilities | 28,828,068 | 22,362,957 | |||||
Stockholders' equity: | |||||||
Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of March 31, 2019 and December 31, 2018, respectively | - | - | |||||
Common stock, par value $.001, 300,000,000 shares authorized; 20,182,654 and 19,120,781 issued; and 19,127,155 and 18,119,282 outstanding, as of March 31, 2019 and December 31, 2018, respectively | 20,183 | 19,121 | |||||
Treasury stock at cost; 1,055,499 and 1,001,499 shares of common stock as of March 31, 2019 and December 31, 2018, respectively | (14,992,694) | (13,953,666) | |||||
Additional paid in capital | 267,875,883 | 250,604,618 | |||||
Accumulated deficit | (159,319,277) | (149,982,489) | |||||
Accumulated other comprehensive loss | (1,073,066) | (1,469,192) | |||||
Total stockholders' equity | 92,511,029 | 85,218,392 | |||||
Total liabilities and stockholders' equity | $121,339,097 | $107,581,349 | |||||
CELLULAR BIOMEDICINE GROUP, INC. | ||||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||
(UNAUDITED) | ||||||
For the Three Months Ended | ||||||
March 31, | ||||||
2019 | 2018 | |||||
Net sales and revenue | $49,265 | $50,961 | ||||
Operating expenses: | ||||||
Cost of sales | 8,087 | 22,300 | ||||
General and administrative | 3,447,734 | 3,188,797 | ||||
Selling and marketing | 42,260 | 74,585 | ||||
Research and development | 5,968,096 | 5,273,951 | ||||
Total operating expenses | 9,466,177 | 8,559,633 | ||||
Operating loss | (9,416,912) | (8,508,672) | ||||
Other income | ||||||
Interest income, net | 97,034 | 5,449 | ||||
Other income (expense), net | (14,510) | 9,200 | ||||
Total other income | 82,524 | 14,649 | ||||
Loss before taxes | (9,334,388) | (8,494,023) | ||||
Income taxes provision | (2,400) | (2,400) | ||||
Net loss | $(9,336,788) | $(8,496,423) | ||||
Other comprehensive income: | ||||||
Cumulative translation adjustment | 396,126 | 818,361 | ||||
Total other comprehensive income: | 396,126 | 818,361 | ||||
Comprehensive loss | $(8,940,662) | $(7,678,062) | ||||
Net loss per share : | ||||||
Basic and diluted | $(0.51) | $(0.51) | ||||
Weighted average common shares outstanding: | ||||||
Basic and diluted | 18,152,429 | 16,742,591 | ||||
CELLULAR BIOMEDICINE GROUP, INC. | ||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
For the Three Months Ended | ||||
March 31, | ||||
2019 | 2018 | |||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||
Net loss | $(9,336,788) | $(8,496,423) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization | 1,329,699 | 1,175,488 | ||
(Gain) loss on disposal of assets | (23) | 935 | ||
Stock based compensation expense | 1,124,562 | 1,134,881 | ||
Interest expense | 39,619 | - | ||
Interest from pledged bank deposits | (117,370) | - | ||
Changes in operating assets and liabilities: | ||||
Accounts receivable | 788 | 81,633 | ||
Other receivables | (43,704) | (4,820) | ||
Prepaid expenses | (1,038,324) | (112,228) | ||
Long-term prepaid expenses and other assets | (378,024) | (436,503) | ||
Accounts payable | 426,027 | 26,596 | ||
Accrued expenses | 12,704 | 731,748 | ||
Other current liabilities | 146,867 | 276,230 | ||
Taxes payable | - | 2,400 | ||
Other non-current liabilities | (71,221) | 8,012 | ||
Net cash used in operating activities | (7,905,188) | (5,612,051) | ||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||
Proceeds from disposal of assets | 359 | - | ||
Purchases of intangibles | (619,165) | - | ||
Purchases of property, plant and equipment | (3,545,355) | (1,082,635) | ||
Net cash used in investing activities | (4,164,161) | (1,082,635) | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||
Net proceeds from the issuance of common stock | 16,038,504 | 30,508,670 | ||
Proceeds from exercise of stock options | 109,261 | 769,723 | ||
Proceeds from short-term debt | 6,131,723 | - | ||
Interest paid | (30,506) | - | ||
Repurchase of treasury stock | (1,039,028) | (715,668) | ||
Net cash provided by financing activities | 21,209,954 | 30,562,725 | ||
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 84,032 | 119,430 | ||
INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 9,224,637 | 23,987,469 | ||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 52,812,880 | 21,568,422 | ||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | $62,037,517 | $45,555,891 | ||
SUPPLEMENTAL CASH FLOW INFORMATION | ||||
Cash paid for income taxes | $2,400 | $- | ||
March 31, | December 31, | |||
2019 | 2018 | |||
Reconciliation of cash, cash equivalents and restricted cash in condensed consolidated statements of cash flows: | ||||
Restricted cash | $17,000,000 | $- | ||
Cash and cash equivalents | 45,037,517 | 52,812,880 | ||
Cash, cash equivalents and restricted cash | $62,037,517 | $52,812,880 | ||
SOURCE Cellular Biomedicine Group
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