Cellular Biomedicine Group Reports First Quarter 2019 Results and Highlights Operational Progress
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 1(st) 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:
http://public.viavid.com/index.php?id=134237
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: derrick.li@cellbiomedgroup.com
Investor Contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Email: cellbiomed@kcsa.com
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
View original content to download multimedia:http://www.prnewswire.com/news-releases/cellular-biomedicine-group-reports-first-quarter-2019-results-and-highlights-operational-progress-300841315.html
SOURCE Cellular Biomedicine Group
