On August 9, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, reported financial results for the second quarter and six months ended June 30, 2019 and provided a review of recent accomplishments and anticipated milestones (Press release, CASI Pharmaceuticals, AUG 9, 2019, View Source [SID1234538536]).
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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Our financial results remained strong through the second quarter of 2019. We look forward to launching the first product from our hematology oncology pipeline, EVOMELA, this quarter and fully transitioning into a commercial organization. We are enthusiastic about our growth and momentum, and continue to pursue additional strategic assets for our pipeline, both in our hematology/oncology space as well as other high quality treatment solutions for patients."
Second Quarter and Recent Business Highlights
Acquired exclusive worldwide rights to commercialize anti-CD19 T-cell therapy in China and worldwide – On June 17, 2019, CASI signed a license agreement for exclusive worldwide commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. CNCT19 targets CD-19, a B-cell surface protein widely expressed during all phases of B-cell development and is a validated target for B-cell driven hematological malignancies. CD19 antigen is the most frequently used biomarker in CAR-T cell therapy clinical trials for hematological malignancies.
Acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103) – On April 17, 2019, CASI acquired exclusive global rights to a novel anti-CD38 monoclonal antibody (CID-103). CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. CID-103 is at the IND/IMPD submission stage of development with initiation of the Phase 1 study targeted for early 2020.
EVOMELA (Melphalan Hydrochloride for Injection) expected to launch in China this quarter – The Company has made significant progress and commercial preparations for the launch of EVOMELA and expects commercialization this quarter. It will be the only approved melphalan product available in China.
Second Quarter and First Half 2019 Financial Results
Cash Position: As of June 30, 2019, CASI had cash and cash equivalents of $70.3 million compared to $99.7 million as of March 31, 2019. The decrease in cash is primarily due to the Black Belt and Juventas investments made during the three months ended June 30, 2019.
R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2019, were $3.0 million and $5.6 million, respectively, compared to $1.7 million and $3.4 million for the same periods in 2018. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, as well as an increase in personnel costs due to growth in the number of employees.
G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2019, were $7.0 million and $12.7 million, respectively, compared to $4.0 million and $5.3 million for the same periods in 2018. The increase in G&A for both the three and six months ended June 30, 2019 was related to a combination of factors primarily resulting from the Company’s growth in China. These factors include an increase in salary, benefits and recruitment expense and facilities costs due to increases in head count, sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product (EVOMELA), professional services fees (including audit and legal services), and an increase in non-cash stock compensation expense largely attributed to stock options issued to the President of CASI China and other new employees.
Net Loss: The Company reported a net loss for the three and six months ended June 30, 2019 of ($15.3) million, or ($0.16) per share, and ($23.4) million, or ($0.25) per share, respectively, compared to ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12) per share for the same periods in 2018. The larger net loss is primarily due to acquired in-process research and development expenses related to the Black Belt license, and the increase in both G&A and R&D expenses primarily due to the Company’s growth in China to support the Company’s first commercial product (EVOMELA).
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, can be found at www.casipharmaceuticals.com.