Cellular Biomedicine Group Reports Second Quarter and First Half of 2019 Financial Results and Business Highlights

6 August 2019

NEW YORK and SHANGHAI, Aug. 6, 2019 /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, 2019.

Cellular Biomedicine Group logo (PRNewsfoto/Cellular Biomedicine Group)

"During the second quarter of 2019, we made strides in advancing CBMG's clinical pipeline in China. This includes expansion to multiple sites, dose escalation and robust patient recruitment for our B cell maturation antigen (BCMA) CAR-T program targeting multiple myeloma (MM). We have finished enrolling patients for the first cohort in a dose escalation study and currently are enrolling patients for the second cohort. We are also expanding the study into multiple sites. We are moving the alpha-fetoprotein T-cell receptor (AFP-TCR-T) program forward and will start to screen and enroll patients in hepatocellular carcinoma (HCC). We are actively preparing for a multisite trial for our AlloJoin® therapy for Knee Osteoarthritis (KOA)," commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG.

Mr. Liu continued, "We continue to leverage the investigator initiated trial (IIT) process in China and plan to initiate these cancer clinical trials in the U.S. when we see positive proof of concept signals in the IIT studies in China. This allows us to prioritize and focus on developing clinical assets with the most potential and best chance to win both in China and globally."

Business Highlights for the Second Quarter and First Half 2019:

  • Advanced myriad of  our immune-oncology (I/O) and regenerative medicine assets for the next stage  in the translational medicine process, comprised of fine-tuning process development, multiple sites trial, increases in patient recruitment, and dose escalation;
  • Preparing to bring our I/O assets to the U.S. market.

Upcoming Clinical Milestones:

  • Present update of clinical data for CBMG's anti-BCMA CAR-T in the fourth quarter of 2019

Financial Results for the Second Quarter and First Half 2019:

  • Net loss allocable to common stock holders for the quarter and six months ended June 30, 2019 was $12.1 million and $21.4 million respectively, compared to $9.2 million and $17.7 million for the same periods in 2018.
  • General and administrative expenses for the quarter and six months ended June 30, 2019 were $3.2 million and $6.6 million, respectively, compared to $3.1 million and $6.3 million for the same periods in 2018.
  • Research and development expenses for the quarter and six months ended June 30, 2019 were $9.1 million and $15 million respectively, compared $6.2 million and $11.4 million for the same periods in 2018, primarily due to the increased clinical development for our leading cell therapy targets.
  • Net cash used in operating activities for first half of 2019 was $18.7 million, compared $13.7 million for the same period in 2018.
  • Cash, cash equivalents and restricted cash was $56.7 million as of June 30, 2019, compared to $62.0 million as of March 31, 2019.

Conference Call and Webcast Information

The Company will host a conference call and webcast with the investment community on Tuesday, August 6th at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-855-327-6838

International: 1-604-235-2082





Webcast:

http://public.viavid.com/index.php?id=135481





Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 10007371

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on August 20, 2019)

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.  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, which partnerships focus on improving manufacturing processes for cell therapies. CBMG currently has ongoing CAR-T Phase I clinical trials in China and 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. 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 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, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K and. 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. 

For more information, please contact:

Company Contact:

Derrick C. Li

Head of Strategy and Investor Relations, CBMG

Phone: 917-717-0994

Email: derrick.li@cellbiomedgroup.com

Investor Contact:

Valter Pinto / Allison Soss

KCSA Strategic Communications

Phone: 212-896-1254 / 212-896-1267

Email: cellbiomed@kcsa.com

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS















For the Six Months Ended





June 30,





2019



2018







CASH FLOWS FROM OPERATING ACTIVITIES:









  Net loss



$(21,433,485)



$(17,682,499)

  Adjustments to reconcile net loss to net cash used in operating activities:









Depreciation and amortization



2,659,038



2,486,145

Loss on disposal of assets



92,487



2,721

Stock based compensation expense



2,113,535



2,477,614

Other than temporary impairment on long-term investments



-



29,424

Interest expense



158,430



-

Interest from pledged bank deposits



(317,696)



-

  Changes in operating assets and liabilities:









Accounts receivable



785



66,451

Other receivables



(19,821)



20,006

Prepaid expenses



(572,978)



(579,479)

Long-term prepaid expenses and other assets



(978,505)



(649,262)

Accounts payable



333,463



114,249

Accrued expenses



(818,327)



(9,892)

Deferred income



-



(4,515)

Other current liabilities



205,632



166,870

Other non-current liabilities



(74,105)



(93,732)

          Net cash used in operating activities



(18,651,547)



(13,655,899)











CASH FLOWS FROM INVESTING ACTIVITIES:









   Proceeds from disposal of assets



359



-

   Putting six-month deposits with the banks



-



(10,000,000)

Purchases of intangibles



(752,449)



(34,172)

Purchases of assets



(7,468,850)



(2,167,527)

          Net cash used in investing activities



(8,220,940)



(12,201,699)











CASH FLOWS FROM FINANCING ACTIVITIES:









Net proceeds from the issuance of common stock



17,166,199



30,506,521

Proceeds from exercise of stock options



150,788



1,165,763

Proceeds from short-term debt



14,546,035



-

Interest paid



(145,159)



-

Repurchase of treasury stock



(1,039,028)



(2,536,064)

          Net cash provided by financing activities



30,678,835



29,136,220











EFFECT OF EXCHANGE RATE CHANGES ON CASH



94,518



(61,177)











INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH



3,900,866



3,217,445

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD



52,812,880



21,568,422

CASH, CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD



$56,713,746



$24,785,867





















SUPPLEMENTAL CASH FLOW INFORMATION



















Cash paid for income taxes



$3,750



$2,400























































June 30,



June 30,





2019



2018

Reconciliation of cash, cash equivalents and  restricted cash in condensed consolidated statements of cash flows:









Restricted cash



$17,000,000



$-

Cash and cash equivalents



39,713,746



24,785,867











Cash, cash equivalents and restricted cash



$56,713,746



$24,785,867













 

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)















June 30,



December 31,





2019



2018











 Assets







Cash and cash equivalents

$39,713,746



$52,812,880

Restricted cash

17,000,000



-

Accounts receivable, less allowance for doubtful accounts of nil and $94,868 as of June 30, 2019 and December 31, 2018, respectively

-



787

Other receivables

440,847



101,909

Prepaid expenses

2,262,527



1,692,135

Total current assets

59,417,120



54,607,711











Investments

240,000



240,000

Property, plant and equipment, net

19,992,728



15,193,761

Right of use

15,203,003



15,938,203

Goodwill

7,678,789



7,678,789

Intangibles, net

7,868,803



7,970,692

Long-term prepaid expenses and other assets

7,286,803



5,952,193

Total assets

$117,687,246



$107,581,349











Liabilities and Stockholders' Equity

















Liabilities:







Short-term debt

$14,546,035



$-

Accounts payable

1,351,930



422,752

Accrued expenses

1,058,273



1,878,926

Taxes payable

28,950



28,950

Other current liabilities

5,186,335



5,710,578

Total current liabilities

22,171,523



8,041,206











Other non-current liabilities

13,338,721



14,321,751

Total liabilities

35,510,244



22,362,957































Stockholders' equity:

















    Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of June 30, 2019 and December 31, 2018, respectively

-



-











    Common stock, par value $.001, 300,000,000 shares authorized; 20,301,425 and 19,120,781 issued; and 19,245,926 and 18,119,282 outstanding, as of June 30, 2019 and December 31, 2018, respectively

20,301



19,121

    Treasury stock at cost; 1,055,499 and 1,001,499 shares of common stock as of June 30, 2019 and December 31, 2018, respectively

(14,992,694)



(13,953,666)

Additional paid in capital

270,033,960



250,604,618

    Accumulated deficit

(171,415,974)



(149,982,489)

    Accumulated other comprehensive loss

(1,468,591)



(1,469,192)

Total stockholders' equity

82,177,002



85,218,392











Total liabilities and stockholders' equity

$117,687,246



$107,581,349











 

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,





2019



2018



2019



2018



















Net sales and revenue



$-



$77,313



$49,265



$128,274



















Operating expenses:

















Cost of sales



-



54,393



8,087



76,693

General and administrative



3,180,709



3,121,695



6,628,443



6,310,492

Selling and marketing



41,252



92,880



83,512



167,465

Research and development



9,062,526



6,166,556



15,030,622



11,440,507

Impairment of long-term investments



-



29,424



-



29,424

         Total operating expenses



12,284,487



9,464,948



21,750,664



18,024,581

Operating loss



(12,284,487)



(9,387,635)



(21,701,399)



(17,896,307)



















Other income :

















Interest income, net



182,017



116,835



279,051



122,284

Other income (expense), net



7,123



84,724



(7,387)



93,924

        Total other income



189,140



201,559



271,664



216,208

Loss before taxes



(12,095,347)



(9,186,076)



(21,429,735)



(17,680,099)



















Income taxes provision



(1,350)



-



(3,750)



(2,400)





































Net loss



$(12,096,697)



$(9,186,076)



$(21,433,485)



$(17,682,499)

Other comprehensive income (loss):

















Cumulative translation adjustment



(395,525)



(1,120,722)



601



(302,361)

Total other comprehensive income (loss):



(395,525)



(1,120,722)



601



(302,361)



















Comprehensive loss



$(12,492,222)



$(10,306,798)



$(21,432,884)



$(17,984,860)



















Net loss per share :

















  Basic and diluted



$(0.63)



$(0.53)



$(1.15)



$(1.03)





































Weighted average common shares outstanding:

















  Basic and diluted



19,223,113



17,487,184



18,690,729



17,116,944



















 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/cellular-biomedicine-group-reports-second-quarter-and-first-half-of-2019-financial-results-and-business-highlights-300897517.html

SOURCE Cellular Biomedicine Group