NEW YORK and SHANGHAI, Aug. 6, 2019 /PRNewswire/ -- Cellular Biomedicine Group Inc. 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 6th 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: | |
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. 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™ (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 | ||||
SOURCE Cellular Biomedicine Group
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