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Cellular Biomedicine Group Reports Q3 2020 Financial Results and Business Highlights

·12 min read

GAITHERSBURG, Md. and SHANGHAI, Nov. 9, 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 third quarter of 2020.

Cellular Biomedicine Group logo (PRNewsfoto/Cellular Biomedicine Group)
Cellular Biomedicine Group logo (PRNewsfoto/Cellular Biomedicine Group)

Tony (Bizuo) Liu, Chief Executive Officer, commented on Q3's progress:

"I'm excited to share our progress in our China Phase I Investigator Initiated Trial (IIT) assessing the safety and efficacy of an anti-CD20/19 bispecific CAR-T, C-CAR039, a 2nd generation novel bi-specific CAR-T therapy targeting both CD19 and CD20 antigens in the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL). C-CAR039's objective is to improve both the response rate and duration of response while limiting antigen escape of CD19 following anti-CD19 CAR-T therapy. C-CAR039 is manufactured in a proprietary process with serum free, semi-automated, and functionally closed platform with reduced vein-to-vein time. Thus far we have seen a complete manufacturing success rate. As of October 30, 2020, 18 of the 21 enrolled patients received single dose C-CAR039 intravenous infusion with a dose range of 1.0 x 106 to 5.0 x 106 CAR-T cells/kg of body weight. 17 patients, including 15 patients with DLBCL, 1 with follicular lymphoma (FL) and 1 with transformed follicular lymphoma (tFL) are evaluable for safety (evaluated by CTCAE V5.0) and 16 patients have one month or longer efficacy data utilizing the 2014 Lugano Classification for the assessment of lymphoma. The median age of evaluable, infused patients was 60 years (range: 28–71 years). The median number of lines of prior therapies was 3 (range: 1-5). 11 of the 17 patients were stage III or IV patients (64.7%).

C-CAR039 treatment was well tolerated with no grade 3 or higher cytokine release syndrome (CRS), and with one grade 1 neurotoxicity event. Reversible grade 1 or 2 CRS was observed in 15/17 (88.2%) of patients. At the one-month efficacy evaluation, 15/16 patients showed clinical improvement with an objective response rate (ORR) of 94%. The best overall response (BOR) includes 14 CR (87.5%, 12 DLBCL, 1 FL and 1 tFL) and 1 partial response (PR). Cytopenia was mostly related to Cy/Flu lymphodepletion. 12 patients have at least 3-months follow-up data. The overall survival (OS) at 3 months is 100%. The median follow-up was 156 days (39-345 days), and the median duration of response (DOR) has not yet been reached. Furthermore, positive correlation between the expansion of C-CAR039 CAR-T cells detected in the peripheral blood of treated patients and tumor regression was observed. We remain optimistic that C-CAR039 shows a potentially competitive safety and a promising efficacy profile. We are planning further development in a multicenter Phase Ib trial in China and in the U.S.

Regarding our C-CAR088 anti-BCMA drug development for multiple myeloma (MM), to date we have infused 26 of the 28 patients enrolled in the IIT study in China. Our abstract for this study has been accepted for an oral presentation on Saturday, December 5, 2020, 1:15pm at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
(https://ash.confex.com/ash/2020/webprogram/Paper138734.html)

We have been utilizing lung cancer tumor specimens for pre-clinical development and manufacturing in China and in the U.S. Upon completion of the Rockville, Maryland site in late Q4, we plan to conduct knowledge transfer from China to the U.S. and utilize our Rockville facility to support early stage U.S. clinical development for C-TIL051 tumor-infiltrating lymphocytes (TIL) for non-small cell lung cancer (NSCLC) and C-CAR039 for NHL.

We are also enrolling patients in China for our off-the-shelf AlloJoin® Phase II trial in the treatment of knee osteoarthritis (KOA). To date we have seen fewer than expected adverse events (AE) and AEs are limited to grades 1 and 2 in the trial participants. We also initiated development in acute respiratory distress syndrome (ARDS) and Alzheimer's disease (AD) using allogeneic human adipose mesenchymal stem cell exosomes (haMSC-Exos) and extracellular vesicles, respectively, in Shanghai, China.

We are happy to report that we secured $25 million and $20 million in financing in August and October, respectively, to support our near-term clinical development and ongoing operations."

Financial Results for the Third Quarter of 2020

  • Net loss allocable to common stockholders for the quarter and nine months ended September 30, 2020 was $17.0 million and $42.1 million respectively, compared to $15.9 million and $37.3 million for the same periods in 2019.

  • General and administrative expenses for the quarter and nine months ended September 30, 2020 were $5.1 million and $11.8 million, respectively, compared to $3.3 million and $10.0 million for the same periods in 2019.

  • Research and development expenses for the quarter and nine months ended September 30, 2020 were $12.6 million and $30.5 million respectively, compared $13.1 million and $28.2 million for the same periods in 2019.

  • Net cash used in operating activities for the nine months ended September 30, 2020 was $33.2 million, compared to $28.4 million for the same period in 2019.

  • Cash and cash equivalents were $26 million as of September 30, 2020, compared to $13.6 million as of June 30, 2020.

  • Short-term debt was $47.9 million as of September 30, 2020, compared to $19.5 million as of June 30, 2020.

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 enrollment of clinical trial patients and expectations relating to the development, safety and efficacy of our drugs, 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:
Sarah Kelly
Director of Corporate Communications, CBMG
Phone: (301) 825-5320
Email: sarah.kelly@cellbiomedgroup.com

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)









September 30,


December 31,




2020


2019








Assets





Cash and cash equivalents

$ 26,028,897


$ 15,443,649


Restricted cash

-


17,000,000


Accounts receivable

32,295


-


Other receivables

297,919


750,943


Prepaid expenses

1,512,172


835,048


Total current assets

27,871,283


34,029,640








Investments

-


240,000


Property, plant and equipment, net

24,686,304


21,434,414


Right of use

18,521,996


20,106,163


Goodwill

7,678,789


7,678,789


Intangibles, net

6,447,085


7,376,940


Long-term prepaid expenses and other assets

7,880,917


6,458,354


Total assets

$ 93,086,374


$ 97,324,300








Liabilities and Stockholders' Equity











Liabilities:





Short-term debt

$ 47,870,256


$ 14,334,398


Accounts payable

2,747,583


2,039,686


Accrued expenses

1,726,200


1,904,829


Taxes payable

30,420


26,245


Other current liabilities

6,922,762


5,367,708


Total current liabilities

59,297,221


23,672,866








Other non-current liabilities

16,465,553


17,933,743


Total liabilities

75,762,774


41,606,609




















Stockholders' equity:











Preferred stock, par value $.001, 50,000,000 shares





authorized; none issued and outstanding as of





September 30, 2020 and December 31, 2019, respectively

-


-








Common stock, par value $.001, 300,000,000 shares authorized;





20,505,852 and 20,359,889 issued; and 19,450,353 and 19,304,390 outstanding,





as of September 30, 2020 and December 31, 2019, respectively

20,506


20,360


Treasury stock at cost; 1,055,499 shares of common stock

(14,992,694)


(14,992,694)


as of September 30, 2020 and December 31, 2019, respectively





Additional paid in capital

275,338,906


272,117,518


Accumulated deficit

(242,084,133)


(199,966,543)


Accumulated other comprehensive loss

(958,985)


(1,460,950)


Total stockholders' equity

17,323,600


55,717,691








Total liabilities and stockholders' equity

$ 93,086,374


$ 97,324,300


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,



2020


2019


2020


2019










Net sales and revenue


$ 32,295


$ -


$ 32,295


$ 49,265










Operating expenses:









Cost of sales


7,618


-


7,618


8,087

General and administrative


5,100,189


3,326,630


11,812,062


9,955,073

Selling and marketing


-


38,267


-


121,779

Research and development


12,611,853


13,126,699


30,457,415


28,157,321

Impairment of investments


-


-


240,000


-

Total operating expenses


17,719,660


16,491,596


42,517,095


38,242,260

Operating loss


(17,687,365)


(16,491,596)


(42,484,800)


(38,192,995)










Other income









Interest income, net


2,774


352,935


38,343


631,986

Other income, net


646,587


274,430


330,642


267,043

Total other income


649,361


627,365


368,985


899,029

Loss before taxes


(17,038,004)


(15,864,231)


(42,115,815)


(37,293,966)










Income taxes credit (provision)


-


325


(1,775)


(3,425)



















Net loss


$ (17,038,004)


$ (15,863,906)


$ (42,117,590)


$ (37,297,391)

Other comprehensive income (loss):









Cumulative translation adjustment


894,793


(303,821)


501,965


(303,220)

Total other comprehensive income (loss):


894,793


(303,821)


501,965


(303,220)










Comprehensive loss


$ (16,143,211)


$ (16,167,727)


$ (41,615,625)


$ (37,600,611)










Net loss per share :









Basic and diluted


$ (0.88)


$ (0.82)


$ (2.17)


$ (1.98)



















Weighted average common shares outstanding:









Basic and diluted


19,433,988


19,256,129


19,390,235


18,881,266

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS








For the Nine Months Ended



September 30,



2020


2019




CASH FLOWS FROM OPERATING ACTIVITIES:





Net loss


$ (42,117,590)


$ (37,297,391)

Adjustments to reconcile net loss to net cash





used in operating activities:





Depreciation and amortization


4,850,349


4,099,029

Loss on disposal of assets


150


32,236

Stock based compensation expense


2,695,850


3,109,410

Other than temporary impairment on long-term investments


240,000


-

Changes in operating assets and liabilities:





Accounts receivable


(32,295)


763

Other receivables


458,119


(491,974)

Prepaid expenses


(658,723)


55,519

Long-term prepaid expenses and other assets


(1,076,037)


(1,920,077)

Accounts payable


1,021,393


4,695,220

Accrued expenses


(207,542)


(359,332)

Other current liabilities


1,735,950


(297,512)

Taxes payable


4,175


(325)

Other non-current liabilities


(84,093)


13,035

Net cash used in operating activities


(33,170,294)


(28,361,399)






CASH FLOWS FROM INVESTING ACTIVITIES:





Proceeds from disposal of assets


-


172,007

Purchases of intangibles


(175,632)


(804,042)

Purchases of assets


(7,057,292)


(8,645,724)

Net cash used in investing activities


(7,232,924)


(9,277,759)






CASH FLOWS FROM FINANCING ACTIVITIES:





Net proceeds from the issuance of common stock


-


17,166,199

Proceeds from exercise of stock options


525,684


195,731

Proceeds from short-term debt


47,851,757


14,546,035

Repayment of short-term debt


(14,315,898)


-

Repurchase of treasury stock


-


(1,039,028)

Net cash provided by financing activities


34,061,543


30,868,937






EFFECT OF EXCHANGE RATE CHANGES ON CASH


(73,077)


(6,982)






DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH


(6,414,752)


(6,777,203)

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD


32,443,649


52,812,880

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD


$ 26,028,897


$ 46,035,677











SUPPLEMENTAL CASH FLOW INFORMATION










Income tax refund


$ 3,200


$ -






Cash paid for income taxes


$ 800


$ 3,750






Interest expense paid


$ 110,982


$ 309,410






Interest income from pledged bank deposits received, netting off withholding tax


$ 460,041


$ -

Cision
Cision

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SOURCE Cellular Biomedicine Group