SHANGHAI, China and CUPERTINO, Calif., Nov. 09, 2017 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical company engaged in the development of immunotherapies for cancer and effective stem cell therapies for degenerative diseases, today reported financial results and business highlights for the third quarter ended September 30, 2017.
“In line with our progress towards patient advocacy, recently we built out our new Shanghai facility, which we believe has one of the largest cell therapy capacities in the world. It houses the newly launched CBMG-GE Joint Laboratory of Cell Therapy and CBMG-Thermo Fisher Scientific Joint Innovation & Application Center. We believe the GE and Thermo Fisher strategic partnerships will further enhance our automation, efficiency and quality systems,” commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer. “We expect to release topline data readout from our Phase I clinical trials for CARD-1 and CALL-1 Chimeric Antigen Receptor (CAR) T-cell treatment for Diffuse Large B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL), and final data readout from our AlloJoin™ Phase I clinical trial for off-the-shelf Knee Osteoarthritis (KOA) therapy in China in the first half of 2018. And we remain optimistic that the U.S. FDA’s recent approval of certain CAR-T therapies for leukemia and lymphoma and last month’s China State Council’s guidelines on clinical trial reform will accelerate the review and approval process and migration to fast-track designation for credible and compliant CAR-T therapies in China, our addressable CAR-T market.”
Third Quarter 2017 Financial Performance
1. Cash Position: $16.3 million cash and cash equivalents as of September 30, 2017 as compared to $27.3 million as of June 30, 2017. In the third quarter of 2017 we used $11 million, which mainly comprised of $4 million for capital expenditure, $1 million in stock repurchase and $6 million for operations. We used $3.3 million for the same periods in 2016 for operations.
2. G&A Expenses: General and administrative expenses for the three months and nine months ended September 30, 2017 were $3.0 million and $9.5 million respectively, compared to $2.8 million and $8.6 million for the same periods in 2016.
3. R&D Expenses: Research and development expenses for the three months and nine months ended September 30, 2017 were $4.1 million and $10.5 million respectively, compared to $2.9 million and $8.3 million for the same periods in 2016.
4. Net Loss: Net loss allocable to common stock holders for the three months ended September 30, 2017 was $6.2 million, compared to $10.7 million for the same period in 2016. The decline in net loss mainly derived from the recognition of other than temporary impairment on stock investment of $4.6 million in 2016, which was one-off loss and there was no such case in 2017.
Business and Operational Highlights for the Third Quarter 2017 to date
- Opened new Shanghai facility in “Pharma Valley” in Zhangjiang High-Tech Park
- Established a strategic partnership with Thermo Fisher Scientific (China) Ltd. to build “CBMG-Thermo Fisher Scientific Joint Innovation & Application Center” in CBMG’s new Shanghai facility
- Launched “CBMG-GE Joint Laboratory of Cell Therapy” with GE Healthcare Life Sciences China in CBMG’s new Shanghai facility
In the next 12 months, we aim to accomplish the following, though there can be no assurances that we will be able to accomplish these goals:
- Confirm the safety and tolerability profile in an investigator-sponsored Phase I trial of C-CAR011 in China in refractory aggressive DLBCL and to initiate a larger Phase II clinical trial as soon as practicable;
- Confirm the safety and tolerability profile in an investigator-sponsored phase I trial of C-CAR011 in relapsed and refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) in China, and to prepare for a follow up multicenter Phase IIb trial;
- Submit to the CFDA an IND package for C-CAR011 in treating patients with CD19+ B-cell malignancies;
- Seek opportunities to file new CAR-T and other patents in China and potentially the rest of the world;
- Continue to seek advanced technologies and partnerships to bolster our position in the CAR-T market in China;
- Bolster R&D resources to fortify our intellectual properties portfolio and scientific development. Continue to develop a competitive Immuno-oncology pipeline for CBMG;
- Assess the changes in the cell therapy competitive landscape and revise our corporate development strategy;
- Complete Chemistry, Manufacturing and Controls (CMC), non-clinical and preclinical study data package to prepare for Allogeneic KOA IND filing in the United States;
- Initiate clinical study to support the Biological License Application (BLA) for Allogeneic KOA study in the United States;
- Bolster R&D resources to fortify our intellectual properties portfolio and scientific development;
- Improve liquidity and fortify our balance sheet by courting institutional investors;
- Evaluate new regenerative medicine technology platform for other indications and review recent development in the competitive landscape;
- Explore new CAR-T opportunities for international collaboration and /or partnership;
- Expand our cell manufacturing capacity and capabilities;
- Evaluate the feasibility of sponsoring a multi-site Phase I/II NSCLC clinical study to support the Biological license application (BLA) for the U.S. and China CD40L GVAX trial in combination with anti-PD1;
- Implement our GE Joint Technology Laboratory to develop control processes for the manufacture of CAR-T and Stem Cell Therapies;
- Implement steps to advance our Thermo Fisher joint Cell Therapy Technology Innovation and Application Center; and
- Elevate our corporate development strategy on maintaining the CAR-T and regenerative medicine dual technology platform.
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. CBMG currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL) and CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), utilizing CBMG’s proprietary and optimized CD19 construct, as well as an ongoing Phase I trial in China for AlloJoin™ (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). 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 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 risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 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 STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) | ||||||||||||||||||
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||||
| September 30, | September 30, | |||||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||||
| Net sales and revenue | $ | 106,787 | $ | 10,012 | $ | 268,126 | $ | 570,102 | ||||||||||
| Operating expenses: | ||||||||||||||||||
| Cost of sales | 55,294 | 9,128 | 130,793 | 835,908 | ||||||||||||||
| General and administrative | 3,023,390 | 2,790,305 | 9,527,730 | 8,638,877 | ||||||||||||||
| Selling and marketing | 85,742 | 124,143 | 280,011 | 342,377 | ||||||||||||||
| Research and development | 4,076,186 | 2,897,736 | 10,469,820 | 8,268,953 | ||||||||||||||
| Impairment of investments | - | 4,611,714 | - | 4,611,714 | ||||||||||||||
| Total operating expenses | 7,240,612 | 10,433,026 | 20,408,354 | 22,697,829 | ||||||||||||||
| Operating loss | (7,133,825 | ) | (10,423,014 | ) | (20,140,228 | ) | (22,127,727 | ) | ||||||||||
| Other income : | ||||||||||||||||||
| Interest income | 23,933 | 22,338 | 113,688 | 57,678 | ||||||||||||||
| Other income (expense) | 907,678 | (17,314 | ) | 1,461,265 | 6,652 | |||||||||||||
| Total other income | 931,611 | 5,024 | 1,574,953 | 64,330 | ||||||||||||||
| Loss before taxes | (6,202,214 | ) | (10,417,990 | ) | (18,565,275 | ) | (22,063,397 | ) | ||||||||||
| Income taxes provision | - | (243,230 | ) | (2,450 | ) | (5,218 | ) | |||||||||||
| Net loss | $ | (6,202,214 | ) | $ | (10,661,220 | ) | $ | (18,567,725 | ) | $ | (22,068,615 | ) | ||||||
| Other comprehensive income (loss): | ||||||||||||||||||
| Cumulative translation adjustment | 291,665 | (58,824 | ) | 637,786 | (314,189 | ) | ||||||||||||
| Unrealized gain (loss) on investments, net of tax | - | - | (240,000 | ) | 5,300,633 | |||||||||||||
| Reclassification adjustments, net of tax, in connection with other-than-temporary impairment of investments | - | (5,557,939 | ) | - | (5,557,939 | ) | ||||||||||||
| Total other comprehensive income (loss): | 291,665 | (5,616,763 | ) | 397,786 | (571,495 | ) | ||||||||||||
| Comprehensive loss | $ | (5,910,549 | ) | $ | (16,277,983 | ) | $ | (18,169,939 | ) | $ | (22,640,110 | ) | ||||||
| Net loss per share : | ||||||||||||||||||
| Basic | $ | (0.43 | ) | $ | (0.75 | ) | $ | (1.30 | ) | $ | (1.67 | ) | ||||||
| Diluted | $ | (0.43 | ) | $ | (0.75 | ) | $ | (1.30 | ) | $ | (1.67 | ) | ||||||
| Weighted average common shares outstanding: | ||||||||||||||||||
| Basic | 14,349,569 | 14,128,465 | 14,310,344 | 13,253,290 | ||||||||||||||
| Diluted | 14,349,569 | 14,128,465 | 14,310,344 | 13,253,290 | ||||||||||||||
| CELLULAR BIOMEDICINE GROUP, INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (UNAUDITED) | |||||||
| September 30, | December 31, | ||||||
| 2017 | 2016 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 16,292,031 | $ | 39,252,432 | |||
| Accounts receivable, less allowance for doubtful amounts of $10,622 | |||||||
| and $10,163 as of September 30, 2017 and December 31, 2016, respectively | 145,384 | 39,974 | |||||
| Other receivables | 935,106 | 412,727 | |||||
| Prepaid expenses | 1,696,082 | 986,951 | |||||
| Total current assets | 19,068,603 | 40,692,084 | |||||
| Investments | 269,424 | 509,424 | |||||
| Property, plant and equipment, net | 11,045,150 | 4,117,739 | |||||
| Goodwill | 7,678,789 | 7,678,789 | |||||
| Intangibles, net | 12,844,078 | 14,092,581 | |||||
| Long-term prepaid expenses and other assets | 2,720,582 | 1,537,850 | |||||
| Total assets | $ | 53,626,626 | $ | 68,628,467 | |||
| Liabilities and Stockholders' Equity | |||||||
| Liabilities: | |||||||
| Accounts payable | $ | 1,236,257 | $ | 216,154 | |||
| Accrued expenses | 728,908 | 1,168,787 | |||||
| Taxes payable | 28,875 | 28,875 | |||||
| Deferred income | 510,419 | - | |||||
| Other current liabilities | 1,357,952 | 950,220 | |||||
| Total current liabilities | 3,862,411 | 2,364,036 | |||||
| Other non-current liabilities | - | 370,477 | |||||
| Total liabilities | 3,862,411 | 2,734,513 | |||||
| Commitments and Contingencies | |||||||
| Stockholders' equity: | |||||||
| Preferred stock, par value $.001, 50,000,000 shares | |||||||
| authorized; none issued and outstanding as of | |||||||
| September 30, 2017 and December 31, 2016, respectively | - | - | |||||
| Common stock, par value $.001, 300,000,000 shares authorized; | |||||||
| 14,375,506 and 14,281,378 issued; and 14,091,181 and 14,281,378 outstanding, | |||||||
| as of September 30, 2017 and December 31, 2016, respectively | 14,376 | 14,281 | |||||
| Treasury stock at cost; 284,325 and nil shares of common stock | |||||||
| as of September 30, 2017 and December 31, 2016, respectively | (2,443,122 | ) | - | ||||
| Additional paid in capital | 157,026,279 | 152,543,052 | |||||
| Accumulated deficit | (104,114,412 | ) | (85,546,687 | ) | |||
| Accumulated other comprehensive income (loss) | (718,906 | ) | (1,116,692 | ) | |||
| Total stockholders' equity | 49,764,215 | 65,893,954 | |||||
| Total liabilities and stockholders' equity | $ | 53,626,626 | $ | 68,628,467 | |||
| CELLULAR BIOMEDICINE GROUP, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2017 | 2016 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (18,567,725 | ) | $ | (22,068,615 | ) | ||
| Adjustments to reconcile net loss to net cash | ||||||||
| used in operating activities: | ||||||||
| Depreciation and amortization | 2,125,391 | 2,034,411 | ||||||
| Loss on disposal of assets | 317 | 1,034 | ||||||
| Stock based compensation expense | 4,240,822 | 3,944,125 | ||||||
| Other than temporary impairment on investments | - | 4,611,714 | ||||||
| Inventory provision | - | 110,145 | ||||||
| Allowance for doubtful account | - | 10,707 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (103,701 | ) | 548,268 | |||||
| Other receivables | (496,229 | ) | 1,275 | |||||
| Inventory | - | 33,398 | ||||||
| Prepaid expenses | (669,592 | ) | (307,924 | ) | ||||
| Taxes recoverable | - | 150,082 | ||||||
| Long-term prepaid expenses and other assets | (936,168 | ) | (376,214 | ) | ||||
| Accounts payable | 1,012,693 | (33,281 | ) | |||||
| Accrued expenses | (475,274 | ) | (167,615 | ) | ||||
| Deferred income | 510,419 | - | ||||||
| Other current liabilities | (206,196 | ) | (528,430 | ) | ||||
| Taxes payable | - | 30,000 | ||||||
| Other non-current liabilities | (386,504 | ) | (65,449 | ) | ||||
| Net cash used in operating activities | (13,951,747 | ) | (12,072,369 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Proceeds from disposal of assets | 286 | - | ||||||
| Purchases of intangibles | (23,562 | ) | (11,160 | ) | ||||
| Purchases of assets | (6,978,348 | ) | (1,642,179 | ) | ||||
| Net cash used in investing activities | (7,001,624 | ) | (1,653,339 | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from the issuance of common stock | - | 42,437,374 | ||||||
| Proceeds from exercise of stock options | 232,910 | 685,712 | ||||||
| Repurchase of treasury stock | (2,443,122 | ) | - | |||||
| Net cash provided by financing activities | (2,210,212 | ) | 43,123,086 | |||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH | 203,182 | (166,089 | ) | |||||
| INCREASE IN CASH AND CASH EQUIVALENTS | (22,960,401 | ) | 29,231,289 | |||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 39,252,432 | 14,884,597 | ||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 16,292,031 | $ | 44,115,886 | ||||
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com