Subject: ERN
Cellular Biomedicine Group (CBMG) Reports Q2, H1 2020 Financial Results and Business Highlights
GAITHERSBURG, Md. and SHANGHAI, Aug. 12, 2020 /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, 2020.
"We held a virtual research & development day in July to provide an update on the six clinical programs we have in development," said Tony (Bizuo) Liu, Chief Executive Officer of CBMG. "Amid the global pandemic, we continue to enroll patients in investigator-initiated trials (IIT) for our clinical programs in China. This includes C-CAR088 anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T cells (CAR-T) for relapsed or refractory multiple myeloma (MM), C-CAR039 anti-CD19/CD20 bi-specific CAR-T for Non-Hodgkin's Lymphoma (NHL), and C-TCR055 alpha-fetoprotein (AFP) TCR-T in hepatocellular carcinoma (HCC). We look forward to the completion of our new Rockville facility later this year to support potential U.S. clinical development for C-CAR039 and C-TIL051 tumor-infiltrating lymphocytes (TIL) for non-small cell lung cancer (NSCLC). We also continue to enroll patients in China for our off-the-shelf AlloJoinTM knee osteoarthritis (KOA) Phase II trial. We plan to submit and present the C-CAR088 and C-CAR039 clinical data at a major conference later this year. We are happy to report that we have recently secured borrowings to support our near-term clinical development."
Clinical Highlights for First Half of 2020 and to Date:
- C-CAR088 for MM*:
- Infused 22 of the 25 enrolled patients; 17 patients with evaluable data for safety and clinical efficacy
- No Grade 4 or higher cytokine release syndrome (CRS)
- No Grade 2 or higher neurotoxicity and dose limiting toxicities
- Cytopenia was mostly related to Cy/Flu lymphodepletion
- 17 patients with 100% best overall response; comprised of 5 complete response, 9 very good partial response and 3 partial response
- C-CAR039 for NHL*:
- Infused 10 of the 16 enrolled patients
- No Grade 3 or higher CRS was observed
- No Grade 2 or higher neurotoxicity
- Cytopenia was mostly related to Cy/Flu lymphodepletion
- Observed encouraging clinical efficacy with limited number of patients
- C-TCR055 in HCC:
- Initiated an early dose escalation study to evaluate the safety and efficacy
- Conducted a poster presentation at the American Association for Cancer Research (AACR) annual meeting: "Selecting Clinical Lead of TCRs Targeting Alpha-Fetoprotein-Positive Liver Cancer on Balance of Risk and Benefit"
- On July 13, 2020, the Company hosted a virtual Research & Development Showcase to present an overview and update on the current state of its clinical and pre-clinical programs.
*: As of June 15, 2020
Business Highlights for First Half of 2020 and to Date:
- Executed a one-year $25 million convertible bridge loan
- Extended the $16 million convertible bridge loan repayment schedule to August, 2021
- Obtained $8.6 million lines of credit
Upcoming Milestones:
- In the next nine months, present our key clinical assets update at major conferences
- In 2021, execute our C-TIL051 to sponsor and initiate an IIT in the U.S. for stage IIIB and IV NSCLC patients refractory to anti-PD1 immunotherapy
- Upon completion, qualify our Rockville facility to support U.S. clinical development
Financial Results for the Second Quarter and First Half 2020 as compared to the same periods in 2019:
- Net loss allocable to common stockholders for the quarter and six months ended June 30, 2020 was $13.5 million and $25.1 million respectively, compared to $12.1 million and $21.4 million
- General and administrative expenses for the quarter and six months ended June 30, 2020 were $3.3 million and $6.7 million, respectively, compared to $3.2 million and $6.6 million
- Research and development expenses for the quarter and six months ended June 30, 2020 were $10.1 million and $17.8 million respectively, compared $9.1 million and $15.0 million
- Net cash used in operating activities for first half of 2020 was $19.8 million, compared to $18.8 million
- Our cash, cash equivalents and restricted cash decreased to $13,581,952 at June 30, 2020 compared to $32,443,649 at December 31, 2019. Subsequent to end of the second quarter, we arranged additional borrowings of $29.3 million to fortify our balance sheet.
About Cellular Biomedicine Group, Inc.
Cellular Biomedicine Group, Inc. (Nasdaq: CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. The company 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. These 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) approved 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 has accepted the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. The NMPA has also accepted CBMG's dossier for an IND application for clinical trials of anti-BCMA CAR-T. CBMG is included in the broad-market Russell 3000® Index 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, specific activities, and other statements that are not descriptions of historical facts, including our statements regarding our clinical trials, enrollment of clinical trial patients, the presentation of key clinical assets updates, our activities with respect to C-TIL051, and the ability of our Rockville site to support U.S. clinical development, 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 any 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, including risks relating to the impact of the COVID-19 pandemic on our operations, including risks associated with the evolving COVID-19 pandemic and actions taken in response to it. Generally, the words "believes," "anticipates," "may," "will," "should," "could," "expect," "plans," "intend," "estimate," "projects," "presents," "potential," "continue" and similar expressions or the negative thereof or comparable terminology are intended to identify forward-looking statements. These statements reflect our current views with respect to future events or to our future activities and involve known and unknown risks, uncertainties and other factors which may cause our actual activities, actions or achievements to be materially different from any future activities, actions or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
Company/Investor Contact:
Derrick C. Li
Head of Strategy and Investor Relations, CBMG
Phone: 917-717-0994
Email: [email protected]
CELLULAR BIOMEDICINE GROUP, INC. | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
(UNAUDITED) | |||||
June 30, | December 31, | ||||
2020 | 2019 | ||||
Assets | |||||
Cash and cash equivalents | $ 13,581,952 | $ 15,443,649 | |||
Restricted cash | - | 17,000,000 | |||
Other receivables | 299,124 | 750,943 | |||
Prepaid expenses | 1,094,270 | 835,048 | |||
Total current assets | 14,975,346 | 34,029,640 | |||
Investments | - | 240,000 | |||
Property, plant and equipment, net | 22,443,525 | 21,434,414 | |||
Right of use | 18,670,312 | 20,106,163 | |||
Goodwill | 7,678,789 | 7,678,789 | |||
Intangibles, net | 6,747,628 | 7,376,940 | |||
Long-term prepaid expenses and other assets | 7,052,583 | 6,458,354 | |||
Total assets (1) | $ 77,568,183 | $ 97,324,300 | |||
Liabilities and Stockholders' Equity | |||||
Liabilities: | |||||
Short-term debt | $ 19,474,822 | $ 14,334,398 | |||
Accounts payable | 1,517,144 | 2,039,686 | |||
Accrued expenses | 1,706,967 | 1,904,829 | |||
Taxes payable | 30,420 | 26,245 | |||
Other current liabilities | 5,722,765 | 5,367,708 | |||
Total current liabilities | 28,452,118 | 23,672,866 | |||
Other non-current liabilities | 16,583,514 | 17,933,743 | |||
Total liabilities | 45,035,632 | 41,606,609 | |||
Stockholders' equity: | |||||
Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | - | - | |||
Common stock, par value $.001, 300,000,000 shares authorized; 20,481,791 and 20,359,889 issued; and 19,426,292 and 19,304,390 outstanding, as of June 30, 2020 and December 31, 2019, respectively | 20,482 | 20,360 | |||
Treasury stock at cost; 1,055,499 shares of common stock as of June 30, 2020 and December 31, 2019 | (14,992,694) | (14,992,694) | |||
Additional paid in capital | 274,404,670 | 272,117,518 | |||
Accumulated deficit | (225,046,129) | (199,966,543) | |||
Accumulated other comprehensive loss | (1,853,778) | (1,460,950) | |||
Total stockholders' equity | 32,532,551 | 55,717,691 | |||
Total liabilities and stockholders' equity | $ 77,568,183 | $ 97,324,300 | |||
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, | ||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||
Net sales and revenue | $ - | $ - | $ - | $ 49,265 | |||||||
Operating expenses: | |||||||||||
Cost of sales | - | - | - | 8,087 | |||||||
General and administrative | 3,280,529 | 3,180,709 | 6,711,873 | 6,628,443 | |||||||
Selling and marketing | - | 41,252 | - | 83,512 | |||||||
Research and development | 10,086,204 | 9,062,526 | 17,845,562 | 15,030,622 | |||||||
Impairment of investments | - | - | 240,000 | - | |||||||
Total operating expenses | 13,366,733 | 12,284,487 | 24,797,435 | 21,750,664 | |||||||
Operating loss | (13,366,733) | (12,284,487) | (24,797,435) | (21,701,399) | |||||||
Other (expense) income | |||||||||||
Interest income, net | 22,797 | 182,017 | 35,569 | 279,051 | |||||||
Other expense, net | (188,153) | 7,123 | (315,945) | (7,387) | |||||||
Total other (expense) income | (165,356) | 189,140 | (280,376) | 271,664 | |||||||
Loss before taxes | (13,532,089) | (12,095,347) | (25,077,811) | (21,429,735) | |||||||
Income taxes provision | - | (1,350) | (1,775) | (3,750) | |||||||
Net loss | $ (13,532,089) | $ (12,096,697) | $ (25,079,586) | $ (21,433,485) | |||||||
Other comprehensive income (loss): | |||||||||||
Cumulative translation adjustment | 43,985 | (395,525) | (392,828) | 601 | |||||||
Total other comprehensive income (loss): | 43,985 | (395,525) | (392,828) | 601 | |||||||
Comprehensive loss | $ (13,488,104) | $ (12,492,222) | $ (25,472,414) | $ (21,432,884) | |||||||
Net loss per share : | |||||||||||
Basic and diluted | $ (0.70) | $ (0.63) | $ (1.29) | $ (1.15) | |||||||
Weighted average common shares outstanding: | |||||||||||
Basic and diluted | 19,395,253 | 19,223,113 | 19,368,118 | 18,690,729 | |||||||
CELLULAR BIOMEDICINE GROUP, INC. | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||
For the Six Months Ended | ||||||
June 30, | ||||||
2020 | 2019 | |||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||
Net loss | $ (25,079,586) | $ (21,433,485) | ||||
Adjustments to reconcile net loss to net cash | ||||||
used in operating activities: | ||||||
Depreciation and amortization | 3,157,829 | 2,659,038 | ||||
Loss on disposal of assets | 149 | 92,487 | ||||
Stock based compensation expense | 1,804,840 | 2,113,535 | ||||
Other than temporary impairment on long-term investments | 240,000 | - | ||||
Changes in operating assets and liabilities: | ||||||
Accounts receivable | - | 785 | ||||
Other receivables | 448,649 | (337,517) | ||||
Prepaid expenses | (270,666) | (572,978) | ||||
Long-term prepaid expenses and other assets | (829,714) | (978,505) | ||||
Accounts payable | (209,527) | 333,463 | ||||
Accrued expenses | (179,881) | (818,327) | ||||
Taxes payable | 4,175 | - | ||||
Other current liabilities | 1,186,828 | 218,903 | ||||
Other non-current liabilities | (90,424) | (74,105) | ||||
Net cash used in operating activities | (19,817,328) | (18,796,706) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||
Proceeds from disposal of assets | - | 359 | ||||
Purchases of intangibles | (141,707) | (752,449) | ||||
Purchases of assets | (4,483,163) | (7,468,850) | ||||
Net cash used in investing activities | (4,624,870) | (8,220,940) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||
Net proceeds from the issuance of common stock | - | 17,166,199 | ||||
Proceeds from exercise of stock options | 482,434 | 150,788 | ||||
Proceeds from short-term debt | 19,456,322 | 14,546,035 | ||||
Repayment of short-term debt | (14,315,898) | - | ||||
Repurchase of treasury stock | - | (1,039,028) | ||||
Net cash provided by financing activities | 5,622,858 | 30,823,994 | ||||
EFFECT OF EXCHANGE RATE CHANGES ON CASH | (42,357) | 94,518 | ||||
(DECREASE)/INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (18,861,697) | 3,900,866 | ||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 32,443,649 | 52,812,880 | ||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | $ 13,581,952 | $ 56,713,746 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION | ||||||
Income tax refund | $ 3,200 | $ - | ||||
Cash paid for income taxes | $ 800 | $ 3,750 | ||||
Interest expense paid | $ 99,271 | $ 145,159 | ||||
Interest income from pledged bank deposits received, netting off withholding tax | $ 460,041 | $ - | ||||
June 30, | June 30, | |||||
2020 | 2019 | |||||
Reconciliation of cash, cash equivalents and restricted cash in condensed consolidated statements of cash flows: | ||||||
Restricted cash | $ - | $ 17,000,000 | ||||
Cash and cash equivalents | 13,581,952 | 39,713,746 | ||||
Cash, cash equivalents and restricted cash | $ 13,581,952 | $ 56,713,746 | ||||
SOURCE Cellular Biomedicine Group
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