- Debuted its next 12-18 months’ immuno-oncology clinical development programs for both hematologic malignancies and solid tumors to key opinion leaders, investment and industry executives
- Licensed patents from the National Cancer Institute (“NCI”) to develop the next generation neoantigen-reactive tumor infiltrating lymphocyte (“TIL”) technology to treat a variety of cancers
- Struck a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah® for Novartis in China
SHANGHAI, China and NEW YORK, Nov. 06, 2018 (GLOBE NEWSWIRE) — Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported financial results and business highlights for the third quarter ended September 30, 2018.
“With $68 million on our balance sheet at end of Q3 we are focusing on developing two cutting-edge immuno-oncology technology platforms on solid tumors and bringing to clinical stage hematologic malignancies CAR-T therapies in anti-BCMA, CD22, CD20 and NKG2D to bolster our cancer drug development pipeline,” commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG. “We plan to move to clinical a novel alpha fetoprotein (“AFP”) specific T-cell receptor (“TCR”) based therapy for hepatocellular carcinoma (“HCC”) early next year. HCC is a primary malignancy of the liver with unmet medical needs, and the majority of the patients are in China. Our team is evaluating the best approach for translating the NCI in-licensed autologous, neoantigen reactive tumor infiltrating lymphocytes (“TIL”) technology to clinical practice. And we are advancing the Allojoin™ and Rejoin™ Knee Osteoarthritis (“KOA”) IND applications with the National Medical Products Administration (“NMPA”), renamed from China Food and Drug Administration (“CFDA”). We have a seasoned research team with substantial global pharma experience in the U.S. and in China, a world-class good manufacturing practice (GMP) capability and a diversified promising portfolio of assets in development. I believe we are well positioned as a leading biopharmaceutical firm that can contribute significantly to help patients who are suffering from aggressive forms of hematologic and solid cancers.”
Third Quarter 2018 Financial Performance
- R&D Expenses: Our focus on development to clinical the TCR and TIL immuno-oncology technology platforms on solid tumors and hematologic malignancies CAR-T therapies resulted in increase of research and development expenses by 61% and 72% for the three months and nine months ended September 30, 2018. The amounts were $6.5 million and $18 million respectively as compared to $4.1 million and $10.5 million for the same periods in 2017.
- G&A Expenses: General and administrative expenses for the three months and nine months ended September 30, 2018 were $3.3 million and $9.6 million respectively, compared to $3.0 million and $9.5 million for the same periods in 2017.
- Net Loss: Net loss allocable to common stock holders for the three months ended September 30, 2018 was $0.72 per share or $12.7 million, compared to $0.43 per share or $6.2 million for the same period in 2017. Excluding one time charge from nonrecurring loss in the GVAX asset impairment, non-GAAP loss for the three months ended September 30, 2018 was $0.56 per share. This increase was a result of increased global spending on R&D.
Business and Operational Highlights for the Third Quarter 2018 to date
- Signed strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah®* (tisagenlecleucel) in China
- Collaboration with Novartis includes $40 million equity investment in CBMG for approximately 9% equity at $27.43/share
- Licensed certain proprietary technology to Novartis for global use
- Licensed from the National Cancer Institute (“NCI”) next generation neoantigen-reactive tumor infiltrating lymphocyte (TIL) technology patents to develop, manufacture, commercialize and to treat a variety of solid tumors.
*Kymriah® is a registered trademark of Novartis AG.
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 12 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, whose partnerships focus on improving manufacturing processes for cell therapies. The CBMG pipeline includes preclinical compounds targeting CD20-, CD22- and B-cell maturation antigen (BCMA)-specific CAR-T compounds, and T-cell receptor (TCR) and tumor infiltrating lymphocyte (TIL) technologies. 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 are ongoing. 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, 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, 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.
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2018 | 2017 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (30,426,263 | ) | $ | (18,567,725 | ) | ||
| Adjustments to reconcile net loss to net cash | ||||||||
| used in operating activities: | ||||||||
| Depreciation and amortization | 3,790,436 | 2,125,391 | ||||||
| Loss on disposal of assets | 4,593 | 317 | ||||||
| Stock based compensation expense | 3,748,082 | 4,240,822 | ||||||
| Other than temporary impairment on investments | 29,424 | – | ||||||
| Impairment on intangible assets | 2,884,896 | – | ||||||
| Allowance for doubtful account | 83,992 | – | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 70,155 | (103,701 | ) | |||||
| Other receivables | (81,892 | ) | (496,229 | ) | ||||
| Prepaid expenses | (376,821 | ) | (669,592 | ) | ||||
| Long-term prepaid expenses and other assets | (333,647 | ) | (936,168 | ) | ||||
| Accounts payable | 41,791 | 1,012,693 | ||||||
| Accrued expenses | 396,639 | (475,274 | ) | |||||
| Deferred income | (12,114 | ) | 510,419 | |||||
| Other current liabilities | 541,074 | (206,196 | ) | |||||
| Other non-current liabilities | 280,319 | (386,504 | ) | |||||
| Net cash used in operating activities | (19,359,336 | ) | (13,951,747 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Proceeds from disposal of assets | 292 | 286 | ||||||
| Putting six-month deposits with the banks | (10,000,000 | ) | – | |||||
| Purchases of intangibles | (33,495 | ) | (23,562 | ) | ||||
| Purchases of assets | (4,438,135 | ) | (6,978,348 | ) | ||||
| Net cash used in investing activities | (14,471,338 | ) | (7,001,624 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of common stock | 70,383,181 | – | ||||||
| Proceeds from exercise of stock options | 2,708,603 | 232,910 | ||||||
| Repurchase of treasury stock | (2,536,064 | ) | (2,443,122 | ) | ||||
| Net cash provided by financing activities | 70,555,720 | (2,210,212 | ) | |||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH | (368,270 | ) | 203,182 | |||||
| INCREASE IN CASH AND CASH EQUIVALENTS | 36,356,776 | (22,960,401 | ) | |||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 21,568,422 | 39,252,432 | ||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 57,925,198 | $ | 16,292,031 | ||||
| SUPPLEMENTAL CASH FLOW INFORMATION | ||||||||
| Cash paid for income taxes | $ | 4,879 | $ | – | ||||
| 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, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Net sales and revenue | $ | 70,431 | $ | 106,787 | $ | 198,705 | $ | 268,126 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 37,483 | 55,294 | 114,176 | 130,793 | ||||||||||||
| General and administrative | 3,315,614 | 3,023,390 | 9,626,106 | 9,527,730 | ||||||||||||
| Selling and marketing | 84,782 | 85,742 | 252,247 | 280,011 | ||||||||||||
| Research and development | 6,545,490 | 4,076,186 | 17,985,997 | 10,469,820 | ||||||||||||
| Impairment on non-current assets | 2,884,896 | – | 2,914,320 | – | ||||||||||||
| Total operating expenses | 12,868,265 | 7,240,612 | 30,892,846 | 20,408,354 | ||||||||||||
| Operating loss | (12,797,834 | ) | (7,133,825 | ) | (30,694,141 | ) | (20,140,228 | ) | ||||||||
| Other income : | ||||||||||||||||
| Interest income | 18,173 | 23,933 | 140,457 | 113,688 | ||||||||||||
| Other income | 38,376 | 907,678 | 132,300 | 1,461,265 | ||||||||||||
| Total other income | 56,549 | 931,611 | 272,757 | 1,574,953 | ||||||||||||
| Loss before taxes | (12,741,285 | ) | (6,202,214 | ) | (30,421,384 | ) | (18,565,275 | ) | ||||||||
| Income taxes provision | (2,479 | ) | – | (4,879 | ) | (2,450 | ) | |||||||||
| Net loss | $ | (12,743,764 | ) | $ | (6,202,214 | ) | $ | (30,426,263 | ) | $ | (18,567,725 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Cumulative translation adjustment | (834,382 | ) | 291,665 | (1,136,743 | ) | 637,786 | ||||||||||
| Unrealized loss on investments, net of tax | – | – | – | (240,000 | ) | |||||||||||
| Total other comprehensive income (loss): | (834,382 | ) | 291,665 | (1,136,743 | ) | 397,786 | ||||||||||
| Comprehensive loss | $ | (13,578,146 | ) | $ | (5,910,549 | ) | $ | (31,563,006 | ) | $ | (18,169,939 | ) | ||||
| Net loss per share : | ||||||||||||||||
| Basic and diluted | $ | (0.72 | ) | $ | (0.43 | ) | $ | (1.76 | ) | $ | (1.30 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 17,604,473 | 14,349,569 | 17,281,240 | 14,310,344 | ||||||||||||
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (UNAUDITED) | ||||||||
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 57,925,198 | $ | 21,568,422 | ||||
| Short-term investment | 10,000,000 | – | ||||||
| Accounts receivable, less allowance for doubtful amounts of $94,648 | ||||||||
| and $10,789 as of September 30, 2018 and December 31, 2017, respectively | 37,592 | 202,887 | ||||||
| Other receivables | 249,771 | 170,842 | ||||||
| Prepaid expenses | 2,132,910 | 1,852,695 | ||||||
| Total current assets | 70,345,471 | 23,794,846 | ||||||
| Long-term investments | 240,000 | 269,424 | ||||||
| Property, plant and equipment, net | 14,313,801 | 12,973,342 | ||||||
| Goodwill | 7,678,789 | 7,678,789 | ||||||
| Intangibles, net | 8,153,428 | 12,419,692 | ||||||
| Long-term prepaid expenses and other assets | 5,683,464 | 4,026,203 | ||||||
| Total assets | $ | 106,414,953 | $ | 61,162,296 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Liabilities: | ||||||||
| Accounts payable | $ | 483,986 | $ | 225,287 | ||||
| Accrued expenses | 1,456,911 | 1,097,327 | ||||||
| Taxes payable | 28,875 | 28,875 | ||||||
| Other current liabilities | 3,960,765 | 2,324,632 | ||||||
| Total current liabilities | 5,930,537 | 3,676,121 | ||||||
| Other non-current liabilities | 441,093 | 183,649 | ||||||
| Total liabilities | 6,371,630 | 3,859,770 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value $.001, 50,000,000 shares | ||||||||
| authorized; none issued and outstanding as of | ||||||||
| September 30, 2018 and December 31, 2017, respectively | – | – | ||||||
| Common stock, par value $.001, 300,000,000 shares authorized; | ||||||||
| 19,093,243 and 15,615,558 issued; and 18,532,475 and 15,188,764 outstanding, | ||||||||
| as of September 30, 2018 and December 31, 2017, respectively | 19,093 | 15,616 | ||||||
| Treasury stock at cost; 560,768 and 426,794 shares of common stock | ||||||||
| as of September 30, 2018 and December 31, 2017, respectively | (6,513,993 | ) | (3,977,929 | ) | ||||
| Additional paid in capital | 249,527,729 | 172,691,339 | ||||||
| Accumulated deficit | (141,463,260 | ) | (111,036,997 | ) | ||||
| Accumulated other comprehensive loss | (1,526,246 | ) | (389,503 | ) | ||||
| Total stockholders’ equity | 100,043,323 | 57,302,526 | ||||||
| Total liabilities and stockholders’ equity | $ | 106,414,953 | $ | 61,162,296 | ||||
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/846b8b11-0233-4554-af34-6a26c91e08b4
