Cellular Biomedicine Group Reports Second Quarter and First Half of 2019 Financial Results and Business Highlights
NEW YORK and SHANGHAI, Aug. 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 second quarter and six months ended June 30, 2019.
"During the second quarter of 2019, we made strides in advancing CBMG's clinical pipeline in China. This includes expansion to multiple sites, dose escalation and robust patient recruitment for our B cell maturation antigen (BCMA) CAR-T program targeting multiple myeloma (MM). We have finished enrolling patients for the first cohort in a dose escalation study and currently are enrolling patients for the second cohort. We are also expanding the study into multiple sites. We are moving the alpha-fetoprotein T-cell receptor (AFP-TCR-T) program forward and will start to screen and enroll patients in hepatocellular carcinoma (HCC). We are actively preparing for a multisite trial for our AlloJoin® therapy for Knee Osteoarthritis (KOA)," commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG.
Mr. Liu continued, "We continue to leverage the investigator initiated trial (IIT) process in China and plan to initiate these cancer clinical trials in the U.S. when we see positive proof of concept signals in the IIT studies in China. This allows us to prioritize and focus on developing clinical assets with the most potential and best chance to win both in China and globally."
Business Highlights for the Second Quarter and First Half 2019:
-- Advanced myriad of our immune-oncology (I/O) and regenerative medicine
assets for the next stage in the translational medicine process,
comprised of fine-tuning process development, multiple sites trial,
increases in patient recruitment, and dose escalation;
-- Preparing to bring our I/O assets to the U.S. market.
Upcoming Clinical Milestones:
-- Present update of clinical data for CBMG's anti-BCMA CAR-T in the fourth
quarter of 2019
Financial Results for the Second Quarter and First Half 2019:
-- Net loss allocable to common stock holders for the quarter and six
months ended June 30, 2019 was $12.1 million and $21.4 million
respectively, compared to $9.2 million and $17.7 million for the same
periods in 2018.
-- General and administrative expenses for the quarter and six months ended
June 30, 2019 were $3.2 million and $6.6 million, respectively, compared
to $3.1 million and $6.3 million for the same periods in 2018.
-- Research and development expenses for the quarter and six months ended
June 30, 2019 were $9.1 million and $15 million respectively, compared
$6.2 million and $11.4 million for the same periods in 2018, primarily
due to the increased clinical development for our leading cell therapy
targets.
-- Net cash used in operating activities for first half of 2019 was $18.7
million, compared $13.7 million for the same period in 2018.
-- Cash, cash equivalents and restricted cash was $56.7 million as of June
30, 2019, compared to $62.0 million as of March 31, 2019.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on Tuesday, August 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=135481
Replay:
Toll-Free: 1-844-512-2921
International: 1-412-317-6671
Conference ID: 10007371
(Available approximately two hours after the completion of the live call
until 11:59 p.m. ET on August 20, 2019)
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Our 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 and a Phase IIb trial in China for Rejoin® autologous Human Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee Osteoarthritis (KOA) as well as a Phase I trial in China for AlloJoin(TM) (CBMG's "Off-the-Shelf" haMPC) 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 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 and. 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 STATEMENTS OF CASH FLOWS
For the Six Months Ended
June 30,
2019 2018
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss $(21,433,485) $(17,682,499)
Adjustments to reconcile net loss to
net cash
used in
operating activities:
Depreciation and amortization 2,659,038 2,486,145
Loss on disposal of assets 92,487 2,721
Stock based compensation expense 2,113,535 2,477,614
Other than temporary impairment on
long-term investments 29,424
Interest expense 158,430
Interest from pledged bank deposits (317,696)
Changes in operating assets and
liabilities:
Accounts receivable 785 66,451
Other receivables (19,821) 20,006
Prepaid expenses (572,978) (579,479)
Long-term prepaid expenses and
other assets (978,505) (649,262)
Accounts payable 333,463 114,249
Accrued expenses (818,327) (9,892)
Deferred income (4,515)
Other current liabilities 205,632 166,870
Other non-current liabilities (74,105) (93,732)
Net cash used in operating
activities (18,651,547) (13,655,899)
CASH FLOWS FROM INVESTING
ACTIVITIES:
Proceeds from disposal of assets 359
Putting six-month deposits with the
banks (10,000,000)
Purchases of intangibles (752,449) (34,172)
Purchases of assets (7,468,850) (2,167,527)
Net cash used in investing
activities (8,220,940) (12,201,699)
CASH FLOWS FROM FINANCING
ACTIVITIES:
Net proceeds from the issuance of
common stock 17,166,199 30,506,521
Proceeds from exercise of stock
options 150,788 1,165,763
Proceeds from short-term debt 14,546,035
Interest paid (145,159)
Repurchase of treasury stock (1,039,028) (2,536,064)
Net cash provided by financing
activities 30,678,835 29,136,220
EFFECT OF EXCHANGE RATE CHANGES ON
CASH 94,518 (61,177)
INCREASE IN CASH, CASH EQUIVALENTS
AND RESTRICTED CASH 3,900,866 3,217,445
CASH, CASH EQUIVALENTS AND
RESTRICTED CASH, BEGINNING OF
PERIOD 52,812,880 21,568,422
CASH, CASH EQUIVALENTS AND
RESTRICTED CASH, END OF PERIOD $56,713,746 $24,785,867
SUPPLEMENTAL CASH FLOW INFORMATION
Cash paid for income taxes $3,750 $2,400
June 30,
June 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 39,713,746 24,785,867
Cash, cash equivalents and
restricted cash $56,713,746 $24,785,867
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
June 30,
December 31,
2019 2018
Assets
Cash and cash equivalents $39,713,746 $52,812,880
Restricted cash 17,000,000 -
Accounts receivable, less
allowance for doubtful
accounts of nil
and $94,868 as of June 30,
2019 and December 31, 2018,
respectively - 787
Other receivables 440,847 101,909
Prepaid expenses 2,262,527 1,692,135
Total current assets 59,417,120 54,607,711
Investments 240,000 240,000
Property, plant and
equipment, net 19,992,728 15,193,761
Right of use 15,203,003 15,938,203
Goodwill 7,678,789 7,678,789
Intangibles, net 7,868,803 7,970,692
Long-term prepaid expenses
and other assets 7,286,803 5,952,193
Total assets $117,687,246 $107,581,349
Liabilities and Stockholders' Equity
Liabilities:
Short-term debt $14,546,035
$-
Accounts payable 1,351,930 422,752
Accrued expenses 1,058,273 1,878,926
Taxes payable 28,950 28,950
Other current liabilities 5,186,335 5,710,578
Total current liabilities 22,171,523 8,041,206
Other non-current
liabilities 13,338,721 14,321,751
Total liabilities 35,510,244 22,362,957
Stockholders' equity:
Preferred stock, par value $.001, 50,000,000 shares
authorized; none issued and outstanding as of
June
30, 2019 and December 31, 2018, respectively
-
Common stock, par value $.001, 300,000,000
shares authorized;
20,301,425
and 19,120,781 issued; and 19,245,926 and
18,119,282 outstanding,
as of
June 30, 2019 and December 31, 2018,
respectively
20,301 19,121
Treasury stock at cost;
1,055,499 and 1,001,499
shares of common stock
as of June 30, 2019
and December 31, 2018,
respectively (14,992,694) (13,953,666)
Additional paid in capital 270,033,960 250,604,618
Accumulated deficit (171,415,974) (149,982,489)
Accumulated other
comprehensive loss (1,468,591) (1,469,192)
Total stockholders' equity 82,177,002 85,218,392
Total liabilities and
stockholders' equity $117,687,246 $107,581,349
CELLULAR BIOMEDICINE GROUP, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
For the Three Months Ended For the Six Months Ended
June 30, June 30,
2019 2018 2019 2018
Net sales and revenue
$- $77,313 $49,265 $128,274
Operating expenses:
Cost of sales 54,393 8,087 76,693
General and administrative 3,180,709 3,121,695 6,628,443 6,310,492
Selling and marketing 41,252 92,880 83,512 167,465
Research and development 9,062,526 6,166,556 15,030,622 11,440,507
Impairment of long-term investments 29,424 29,424
Total operating expenses 12,284,487 9,464,948 21,750,664 18,024,581
Operating loss (12,284,487) (9,387,635) (21,701,399) (17,896,307)
Other income :
Interest income, net 182,017 116,835 279,051 122,284
Other income (expense), net 7,123 84,724 (7,387) 93,924
Total other income 189,140 201,559 271,664 216,208
Loss before taxes (12,095,347) (9,186,076) (21,429,735) (17,680,099)
Income taxes provision (1,350) (3,750) (2,400)
Net loss $(12,096,697) $(9,186,076) $(21,433,485) $(17,682,499)
Other comprehensive income (loss):
Cumulative translation adjustment (395,525) (1,120,722) 601 (302,361)
Total other comprehensive income (loss): (395,525) (1,120,722) 601 (302,361)
Comprehensive loss $(12,492,222) $(10,306,798) $(21,432,884) $(17,984,860)
Net loss per share :
Basic and diluted $(0.63) $(0.53) $(1.15) $(1.03)
Weighted average common shares
outstanding:
Basic and diluted 19,223,113 17,487,184 18,690,729 17,116,944
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SOURCE Cellular Biomedicine Group
