PR Newswire | Aug 12, 2020 04:31PM EDT

Business Highlights

08/12 15:30 CDT

Cellular Biomedicine Group (CBMG) Reports Q2, H1 2020 Financial Results and Business Highlights GAITHERSBURG, Md. and SHANGHAI, Aug. 12, 2020

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(r), 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(r) 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(r) Index the small-cap Russell 2000(r) 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. LiHead of Strategy and Investor Relations, CBMGPhone: 917-717-0994Email: derrick.li@cellbiomedgroup.com

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 andDecember 31, 2019, respectively

Common stock, par value $.001,300,000,000 shares authorized; 20,481,791and 20,359,889 issued; and 19,426,292 and 20,482 20,36019,304,390 outstanding, as of June 30, 2020and December 31, 2019, respectively

Treasury stock at cost; 1,055,499 sharesof common stock as of June 30, 2020 and (14,992,694) (14,992,694)December 31, 2019

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 $ - $ - $ - $ 49,265revenue

Operatingexpenses:

Cost of sales - - - 8,087

General and 3,280,529 3,180,709 6,711,873 6,628,443administrative

Selling and - 41,252 - 83,512marketing

Research and 10,086,204 9,062,526 17,845,562 15,030,622development

Impairment of - - 240,000 -investments

Totaloperating 13,366,733 12,284,487 24,797,435 21,750,664expenses

Operating loss (13,366,733) (12,284,487) (24,797,435) (21,701,399)

Other(expense)income

Interest 22,797 182,017 35,569 279,051income, net

Other expense, (188,153) 7,123 (315,945) (7,387)net

Totalother (165,356) 189,140 (280,376) 271,664(expense)income

Loss before (13,532,089) (12,095,347) (25,077,811) (21,429,735)taxes

Income taxes - (1,350) (1,775) (3,750)provision

Net loss $ (13,532,089) $ (12,096,697) $ (25,079,586) $ (21,433,485)

Othercomprehensiveincome (loss):

Cumulativetranslation 43,985 (395,525) (392,828) 601adjustment

Total othercomprehensive 43,985 (395,525) (392,828) 601income (loss):

Comprehensive $ (13,488,104) $ (12,492,222) $ (25,472,414) $ (21,432,884)loss

Net loss pershare :

Basic and $ (0.70) $ (0.63) $ (1.29) $ (1.15)diluted

Weightedaverage commonsharesoutstanding:

Basic and 19,395,253 19,223,113 19,368,118 18,690,729diluted

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Six Months Ended

June 30,

2020 2019

CASH FLOWS FROM OPERATINGACTIVITIES:

Net loss $ (25,079,586) $ (21,433,485)

Adjustments toreconcile net loss to netcash

used in operatingactivities:

Depreciation and 3,157,829 2,659,038amortization

Loss on disposal of 149 92,487assets

Stock based compensation 1,804,840 2,113,535expense

Other than temporaryimpairment on long-term 240,000 -investments

Changes in operatingassets and liabilities:

Accounts receivable - 785

Other receivables 448,649 (337,517)

Prepaid expenses (270,666) (572,978)

Long-term prepaid (829,714) (978,505)expenses and other assets

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 (90,424) (74,105)liabilities

Net cash used (19,817,328) (18,796,706)in operating activities

CASH FLOWS FROM INVESTINGACTIVITIES:

Proceeds from disposal - 359of assets

Purchases of intangibles (141,707) (752,449)

Purchases of assets (4,483,163) (7,468,850)

Net cash used (4,624,870) (8,220,940)in investing activities

CASH FLOWS FROM FINANCINGACTIVITIES:

Net proceeds from the - 17,166,199issuance of common stock

Proceeds from exercise of 482,434 150,788stock options

Proceeds from short-term 19,456,322 14,546,035debt

Repayment of short-term (14,315,898) -debt

Repurchase of treasury - (1,039,028)stock

Net cashprovided by financing 5,622,858 30,823,994activities

EFFECT OF EXCHANGE RATE (42,357) 94,518CHANGES ON CASH

(DECREASE)/INCREASE INCASH, CASH EQUIVALENTS (18,861,697) 3,900,866AND RESTRICTED CASH

CASH, CASH EQUIVALENTSAND RESTRICTED CASH, 32,443,649 52,812,880BEGINNING OF PERIOD

CASH, CASH EQUIVALENTSAND RESTRICTED CASH, END $ 13,581,952 $ 56,713,746OF PERIOD

SUPPLEMENTAL CASH FLOWINFORMATION

Income tax refund $ 3,200 $ -

Cash paid for income $ 800 $ 3,750taxes

Interest expense paid $ 99,271 $ 145,159

Interest income frompledged bank deposits $ 460,041 $ -received, netting offwithholding tax

June 30, June 30,

2020 2019

Reconciliation of cash,cash equivalents and restricted cash incondensed consolidatedstatements of cash flows:

Restricted cash $ - $ 17,000,000

Cash and cash equivalents 13,581,952 39,713,746

Cash, cash equivalents $ 13,581,952 $ 56,713,746and restricted cash

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SOURCE Cellular Biomedicine Group