Cellular Biomedicine Group Reports Third Quarter of 2019 Financial Results and Business Highlights
NEW YORK and SHANGHAI, Nov. 6, 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 third quarter of 2019.
"During the third quarter of 2019, we made great strides in both corporate and clinical progress. We started our U.S. expansion for research and clinical development in a new 22,000 square foot facility in Rockville, Maryland in October 2019. This milestone will allow us to foster strategic partnerships, develop new innovations and support continued development of CBMG's cell therapy-based immune-oncology assets that have shown promise in early proof-of-concept trials in China," said Tony (Bizuo) Liu, Chief Executive Officer for the Company.
"We also had continued progress on the clinical side, with the initiation of our Phase II clinical trial in China of AlloJoin® therapy for knee osteoarthritis (KOA). Additionally, our autologous stem cell therapy program for KOA, ReJoin®, was accepted by the NMPA in China to begin a Phase II clinical trial. We are excited about our regenerative medicine programs as we are currently the only company that has received two clinical trial acceptances for any stem cell program in China."
Mr. Liu continued, "Presentations of our pre-clinical and clinical data at upcoming medical conferences later this year will demonstrate continued focus on our immune-oncology pipeline and we are proud to provide an update of our commitment to cancer immunotherapy."
Third Quarter 2019 and Other Recent Corporate Developments
-- New facility to expand research and development and to support clinical
development in Rockville, MD
-- Initiation of AlloJoin® therapy for multiple-site Knee Osteoarthritis
Phase II clinical trial
-- ReJoin® therapy received stem cell drug application acceptance for
Phase II clinical trial by NMPA
Upcoming Clinical and Preclinical Presentations:
-- Society of Immunotherapy in Cancer ("SITC") 34(th) Annual MeetingPoster
PresentationThe Next Generation "Off-The-Shelf" Universal CAR For
Adoptive Immunotherapy (Abstract ID: P229)Friday, November 8, 2019 -
7:00 AM - 8:00 AM ETGaylord National Hotel & Convention Center, National
Harbor, MD
-- American Society of Hematology ("ASH") 61(st) Annual Meeting and
ExpositionOral PresentationDeveloping a Novel Anti-BCMA CAR-T For
Relapsed or Refractory Multiple Myeloma (Submission ID: 125372)Saturday,
December 7, 2019 - 7:45 AM - 8:00 AM ETOrange County Convention Center
(OCCC), Orlando, FL
Financial Results for the Third Quarter of 2019
-- Net loss allocable to common stock holders for the quarter and nine
months ended September 30, 2019 was $15.9 million and $37.3 million
respectively, compared to $12.7 million and $30.4 million for the same
periods in 2018.
-- General and administrative expenses for the quarter and nine months
ended September 30, 2019 were $3.3 million and $10.0 million,
respectively, compared to $3.3 million and $9.6 million for the same
periods in 2018.
-- Research and development expenses for the quarter and nine months ended
September 30, 2019 were $13.1 million and $28.2 million respectively,
compared $6.5 million and $18.0 million for the same periods in 2018.
-- Net cash used in operating activities for the nine months ended
September 30, 2019 was $28.1 million, compared to $19.4 million for the
same period in 2018.
-- Cash balance was $29.0 million as of September 30, 2019, compared to
$39.7 million as of June 30, 2019.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on Wednesday, November 6(th) at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.
Live
Call:
Toll-Free: 1-855-327-6838
International: 1-604-235-2082
Webcast:
http://public.viavid.com/index.php?id=136796
Replay:
Toll-Free: 1-844-512-2921
International: 1-412-317-6671
Conference ID: 10007976
(Available approximately two hours after the completion of the live call
until 11:59 p.m. ET on November 20, 2019)
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) 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. The Company's GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Its 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. The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy 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 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, 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, 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.
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)
September 30,
December 31,
2019 2018
Assets
Cash and cash equivalents $29,035,677 $52,812,880
Restricted cash 17,000,000 -
Accounts receivable, less
allowance for doubtful
accounts of nil and $94,868
as of September 30, 2019
and December 31, 2018,
respectively - 787
Other receivables 591,271 101,909
Prepaid expenses 1,589,479 1,692,135
Total current assets 48,216,427 54,607,711
Investments 240,000 240,000
Property, plant and
equipment, net 19,856,287 15,193,761
Right of use 14,298,613 15,938,203
Goodwill 7,678,789 7,678,789
Intangibles, net 7,521,523 7,970,692
Long-term prepaid expenses
and other assets 7,640,535 5,952,193
Total assets $105,452,174 $107,581,349
Liabilities and Stockholders' Equity
Liabilities:
Short-term debt $14,138,419
$-
Accounts payable 5,686,023 422,752
Accrued expenses 1,477,174 1,878,926
Taxes payable 28,625 28,950
Other current liabilities 4,526,594 5,710,578
Total current liabilities 25,856,835 8,041,206
Other non-current
liabilities 12,545,245 14,321,751
Total liabilities 38,402,080 22,362,957
Stockholders' equity:
Preferred stock, par value
$.001, 50,000,000 shares
authorized; none issued and
outstanding as of September
30, 2019 and December 31,
2018, respectively -
Common stock, par value
$.001, 300,000,000 shares
authorized; 20,327,722 and
19,120,781 issued; and
19,272,223 and 18,119,282
outstanding, as of
September 30, 2019 and
December 31, 2018,
respectively 20,328 19,121
Treasury stock at cost;
1,055,499 and 1,001,499
shares of common stock as
of September 30, 2019 and
December 31, 2018,
respectively (14,992,694) (13,953,666)
Additional paid in capital 271,074,752 250,604,618
Accumulated deficit (187,279,880) (149,982,489)
Accumulated other
comprehensive loss (1,772,412) (1,469,192)
Total stockholders' equity 67,050,094 85,218,392
Total liabilities and
stockholders' equity $105,452,174 $107,581,349
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
---
2019 2018 2019 2018
---
Net sales and revenue
$- $70,431 $49,265 $198,705
Operating expenses:
Cost of sales 37,483 8,087 114,176
General and administrative 3,326,630 3,315,614 9,955,073 9,626,106
Selling and marketing 38,267 84,782 121,779 252,247
Research and development 13,126,699 6,545,490 28,157,321 17,985,997
Impairment of non-current
assets 2,884,896 2,914,320
Total operating expenses 16,491,596 12,868,265 38,242,260 30,892,846
---
Operating loss (16,491,596) (12,797,834) (38,192,995) (30,694,141)
---
Other income :
Interest income, net 352,935 18,173 631,986 140,457
Other income, net 274,430 38,376 267,043 132,300
Total other income 627,365 56,549 899,029 272,757
---
Loss before taxes (15,864,231) (12,741,285) (37,293,966) (30,421,384)
Income taxes credit (provision) 325 (2,479) (3,425) (4,879)
Net loss $(15,863,906) $(12,743,764) $(37,297,391) $(30,426,263)
---
Other comprehensive loss:
Cumulative translation
adjustment (303,821) (834,382) (303,220) (1,136,743)
Total other comprehensive loss: (303,821) (834,382) (303,220) (1,136,743)
Comprehensive loss $(16,167,727) $(13,578,146) $(37,600,611) $(31,563,006)
===
Net loss per share :
Basic and diluted $(0.82) $(0.72) $(1.98) $(1.76)
===
Weighted average common shares outstanding:
Basic and diluted 19,256,129 17,604,473 18,881,266 17,281,240
===
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Nine Months Ended
September 30,
2019 2018
---
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $(37,297,391) $(30,426,263)
Adjustments to reconcile net loss to net cash
used in operating
activities:
Depreciation and amortization 4,099,029 3,790,436
Loss on disposal of assets 32,236 4,593
Stock based compensation expense 3,109,410 3,748,082
Other than temporary impairment on long-term
investments 29,424
Impairment on intangible assets 2,884,896
Allowance for doubtful account 83,992
Interest expense 320,709
Interest from pledged bank deposits (371,671)
Changes in operating assets and liabilities:
Accounts receivable 763 70,155
Other receivables (120,303) (81,892)
Prepaid expenses 55,519 (376,821)
Long-term prepaid expenses and other assets (1,920,077) (333,647)
Accounts payable 4,695,220 41,791
Accrued expenses (359,332) 396,639
Deferred income (12,114)
Other current liabilities (308,811) 541,074
Taxes payable (325)
Other non-current liabilities 13,035 280,319
Net cash used in operating activities (28,051,989) (19,359,336)
---
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from disposal of assets 172,007 292
Putting six-month deposits with the banks (10,000,000)
Purchases of intangibles (804,042) (33,495)
Purchases of assets (8,645,724) (4,438,135)
Net cash used in investing activities (9,277,759) (14,471,338)
---
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from the issuance of common stock 17,166,199 70,383,181
Proceeds from exercise of stock options 195,731 2,708,603
Proceeds from short-term debt 14,546,035
Interest paid (309,410)
Repurchase of treasury stock (1,039,028) (2,536,064)
Net cash provided by financing activities 30,559,527 70,555,720
---
EFFECT OF EXCHANGE RATE CHANGES ON CASH (6,982) (368,270)
INCREASE/(DECREASE) IN CASH, CASH EQUIVALENTS
AND RESTRICTED CASH (6,777,203) 36,356,776
CASH, CASH EQUIVALENTS AND RESTRICTED CASH,
BEGINNING OF PERIOD 52,812,880 21,568,422
---
CASH, CASH EQUIVALENTS AND RESTRICTED CASH,
END OF PERIOD $46,035,677 $57,925,198
===
SUPPLEMENTAL CASH FLOW INFORMATION
Cash paid for income taxes $3,750 $4,879
===
September 30, September 30,
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 29,035,677 57,925,198
Cash, cash equivalents and restricted cash $46,035,677 $57,925,198
===
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SOURCE Cellular Biomedicine Group
