ROCKVILLE, Md.

and

BEIJING

,

May 13, 2021

/PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results for the first quarter of 2021.

Wei-Wu He

, Ph.D., CASI’s Chairman, and Chief Executive Officer, commented, “We are pleased to report

$5.7 million

EVOMELA

^®

revenues for the quarter. For the full year 2021, we expect to meet our guidance of greater than 50% revenue growth.  In addition to upward trend in EVOMELA revenue, our first quarter was marked by our new

China

partnership with Cleave Therapeutics for CB-5339, an exciting first-in-class VCP/p97 inhibitor being investigated for hematological malignancies and solid tumors. We also completed a

$32.5 million

capital raise at the end of March, from new fundamentally-driven, healthcare-dedicated investors, to strengthen our balance sheet.”

Dr. He continued, “I am thrilled with the progress we are seeing across our hematology oncology product portfolio. With respect to our commercial asset CNCT-19 (CD19 CAR-T), our partner Juventas is making excellent progress with their current registration trials in B-NHL and B-ALL and is expecting to file NDAs in

China

by the end of 2021. Our CID-103 (anti-CD38 monoclonal antibody) Phase I trial remains on track with first patient dosing expected later this month, BI-1206 (anti-FcyRIIB monoclonal antibody) is on track with our China IND submission expected this year.  We are excited by our momentum and will continue to execute on a number of key milestones across our broad portfolio in the quarters ahead.”

First Quarter 2021 Financial Results

• Revenues consisted primarily of product sales of EVOMELA that launched in August of 2019. Revenue was
  
  $5.7 million
  
  for the three months ended
  
  March 31, 2021
  
  , compared with
  
  $3.4
  
  for the three months ended
  
  March 31, 2020
  
  .
• Costs of revenues were
  
  $2.4 million
  
  for the quarter ended
  
  March 31, 2021
  
  , compared with
  
  $3.2
  
  for the quarter ended
  
  March 31, 2020
  
  . The decrease in cost of revenues is due to the new alternate manufacturer now in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA
  
  ^®
  
  . The decrease was partially offset by the continued growth in EVOMELA
  
  ^®
  
  sales.
• Research and development expenses for the three months ended
  
  March 31, 2021
  
  were
  
  $5.3 million
  
  , compared with
  
  $3.0 million
  
  for the three months ended
  
  March 31, 2020
  
  . The increases in R&D expenses are primarily due to an increase in R&D expenses incurred related to the development of CID-103. Included in our research and development expenses for the three months ended
  
  March 31, 2021
  
  are direct project costs of
  
  $3.5 million
  
  for preclinical development activities, primarily related to our CID-103 program,
  
  $0.5 million
  
  related to our ANDAs acquired in 2018, and
  
  $0.4 million
  
  for drugs in-licensed from Acrotech (previously Spectrum).
• General and administrative expenses for the first quarter of 2021 were
  
  $5.5 million
  
  , compared with
  
  $4.1 million
  
  for the same period in 2020. The increase in general and administrative expenses was primarily due to an increase in headcount and payroll expenses as the Company continues to build its sales and marketing force.
• Selling and marketing expenses for the first quarter 2021 were
  
  $2.7 million
  
  , compared with
  
  $1.3
  
  for the same period in 2020.
• Net loss for the first quarter of 2021 was
  
  $13.7 million
  
  compared to
  
  $8.2 million
  
  for the same period in 2020.
• As of
  
  March 31, 2021
  
  , the Company had cash and cash equivalents of
  
  $68.1 million
  
  compared to
  
  $57.1million
  
  as of
  
  December 31, 2020
  
  .

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended

March 31, 2021

, can be found at

www.casipharmaceuticals.com

.

Conference Call

The Company will host a conference call reviewing the first quarter highlights at

8:00 a.m. ET on Thursday

, May 13, 2021. On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing (833) 420-0382 (U.S.), 8008700181 (

China

), 58086567 (

Hong Kong

) to listen to the live conference call. The conference ID number for the live call is 7478587.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in

China

,

the United States

, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater

China

market leveraging the Company’s

China

-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in

China

are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (

China

) Co., Ltd., which is located in

Beijing, China

. The Company has built a commercial team of more than 80 hematology and oncology sales and marketing specialists based in

China

. More information on CASI is available at

www.casipharmaceuticals.com

.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations, and goals. Forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market; the volatility in the market price of our common stock; the outbreak of the COVID-19 pandemic and its effects on global markets and supply chains; the risk of substantial dilution of existing stockholders in future stock issuances; the difficulty of executing our business strategy in

China

; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration (FDA), National Medical Products Administration (NMPA), or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; our ability to design and implement a development plan for our ANDAs held by CASI Wuxi; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest stockholders and our Chairman and CEO that differ from our other stockholders; and risks related to the development of a new manufacturing facility by CASI Wuxi. Such factors, among others, could have a material adverse effect upon our business, results of operations, and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition, and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at

www.sec.gov

.

EVOMELA


^®

is

proprietary to Acrotech Biopharma LLC and its affiliates.

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SOURCE CASI Pharmaceuticals, Inc.