Cellular Biomedicine Group Reports Q3 2020 Financial Results and Business Highlights

 

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.

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

 

$                      -

 

 

 

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SOURCE Cellular Biomedicine Group

 
 
Company Codes: NASDAQ-NMS:CBMG
 

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