CASI PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2023 BUSINESS AND FINANCIAL UPDATES

Angelena Iglesia



BEIJING


,


Aug. 11, 2023


/PRNewswire/ — CASI Prescription drugs, Inc. (Nasdaq: CASI), a biopharmaceutical firm targeted on growing and commercializing revolutionary therapeutics and pharmaceutical merchandise, immediately reported monetary outcomes for the quarter ended

June 30

, 2023.

CASI PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2023 BUSINESS AND FINANCIAL UPDATES


Wei-Wu He

, Ph.D., CASI’s Chairman and Chief Govt Officer, commented, “We’re happy to report

$9.8 million

gross sales income for the second quarter of 2023. This can be a 15% enhance in comparison with the identical interval final 12 months and an 18% of enhance from the primary quarter of 2023.”

Dr. He continued, “Development, improvement, and commercialization of the portfolio stays our strategic focus.  We’ve achieved a serious milestone with our associate Juventas Biotechnology (

Tianjin

) Co., Ltd. (“Juventas”) on the CNCT-19 CAR-T Cell remedy. CNCT-19’s New Drug Utility (NDA) was accepted by Nationwide Medical Merchandise Administration (NMPA) in

December 2022

. We at the moment are diligently getting ready for the anticipated CNCT-19 launch in

China

. We’re advancing the medical improvement of BI-1206 together with rituximab and presently endeavor the enrollment of sufferers for the second cohort of the section I trial in

China

.  We’re transitioning the event of CID-103 into

China

for the malignant hematology indications. As well as, we acquired world rights for CB-5339 from Cleave Therapeutics in July. On

August 1


st

, we introduced the switch of license of Folotyn

®

in

China

from Mundipharma Worldwide Company Restricted, Mundipharma Medical Firm, and Acrotech Biopharma Inc.. We proceed to advance our portfolio by executing on a number of milestones in addition to bringing in new potential alternatives for synergy within the quarters forward.”



Second Quarter 2023 Monetary Highlights

  • Income was

    $9.8 million

    for the three months ended

    June 30, 2023

    , in comparison with

    $8.6 million

    for the three months ended

    June 30, 2022

    .
  • Prices of revenues have been

    $4.0 million

    for the three months ended

    June 30, 2023

    , in comparison with

    $3.6 million

    for the three months ended

    June 30, 2022

    .
  • Analysis and improvement bills for the three months ended

    June 30, 2023

    have been

    $2.6 million

    , in contrast with

    $3.9 million

    for the three months ended

    June 30, 2022

    .
  • Common and administrative bills for the three months ended

    June 30, 2023

    have been

    $7.7 million

    , in contrast with

    $5.5 million

    for the three months ended

    June 30, 2022

    . The rise was primarily attributable to the

    $2.2 million

    share-based compensation bills allotted to basic and administrative bills associated to the Firm’s modification to sure share choices granted beneath the 2011 Lengthy-term Incentive Plan and 2021 Lengthy-term Incentive Plan.
  • Promoting and advertising and marketing bills for the three months ended

    June 30, 2023

    have been

    $4.8 million

    , in contrast with

    $3.4 million

    for the three months ended

    June 30, 2022

    . The rise was primarily attributable to journey and convention bills incurred for our business actions.
  • As of

    June 30, 2023

    , CASI had money, money equivalents and short-term investments of

    $36.8 million

    .


About CASI Prescription drugs

CASI Prescription drugs, Inc. is a biopharmaceutical firm targeted on growing and commercializing revolutionary therapeutics and pharmaceutical merchandise in

China

,

america

, and all through the world.  The Firm is concentrated on buying, growing, and commercializing merchandise that increase its hematology oncology therapeutic focus in addition to different areas of unmet medical want. The Firm intends to execute its plan to grow to be a frontrunner by launching medicines within the higher

China

market, leveraging the Firm’s  China-based regulatory and business competencies and its world drug improvement experience. The Firm’s operations in

China

are carried out by its wholly-owned subsidiary, CASI Prescription drugs (

China

) Co., Ltd., positioned in

Beijing, China

. Extra data on CASI is on the market at

www.casipharmaceuticals.com

.


Ahead-Trying Statements

This information launch accommodates forward-looking statements inside the which means of the Personal Securities Litigation Reform Act with respect to the outlook for expectations for future monetary or enterprise efficiency, methods, expectations, and objectives. Ahead-looking statements are topic to quite a few assumptions, dangers, and uncertainties, which change over time. Ahead-looking statements converse solely as of the date they’re made, and no responsibility to replace forward-looking statements is assumed. Precise outcomes might differ materially from these at the moment anticipated resulting from numerous components, together with: the danger that we could also be unable to proceed as a going concern because of our lack of ability to lift ample capital for our operational wants; the likelihood that we could also be delisted from buying and selling on The Nasdaq Capital Market; the volatility available in the market value of our peculiar shares; the danger of considerable dilution of present shareholders in future share issuances; the issue of executing our enterprise technique in

China

; our lack of ability to enter into strategic partnerships for the event, commercialization, manufacturing and distribution of our proposed product candidates or future candidates, together with with respect to BI-1206, CB-5339 and CID-103; our lack of expertise in manufacturing merchandise and uncertainty about our sources and capabilities to take action on a medical or business scale; dangers regarding the commercialization, if any, of our merchandise and proposed merchandise (comparable to advertising and marketing, security, regulatory, patent, product legal responsibility, provide, competitors and different dangers); our lack of ability to foretell when or if our product candidates might be accredited for advertising and marketing by the U.S. Meals and Drug Administration (FDA), Nationwide Medical Merchandise Administration (NMPA), or different regulatory authorities; our lack of ability to enter into strategic partnerships for the event, commercialization, manufacturing and distribution of our proposed product candidates or future candidates, together with with respect to our partnerships with Juventas and BioInvent; the dangers regarding the necessity for added capital and the uncertainty of securing further funding on favorable phrases; the dangers related to our product candidates, and the dangers related to our different early-stage merchandise beneath improvement; the danger that lead to preclinical and medical fashions will not be essentially indicative of medical outcomes; uncertainties regarding preclinical and medical trials, together with delays to the graduation of such trials; our capability to guard our mental property rights; the dearth of success within the medical improvement of any of our merchandise; and our dependence on third events; the dangers associated to our dependence on Juventas to conduct the medical improvement of CNCT19 and to associate with us to co-market CNCT19; dangers associated to our dependence on Juventas to make sure the patent safety and prosecution for CNCT19; dangers regarding the commercialization, if any, of our proposed merchandise (comparable to advertising and marketing, security, regulatory, patent, product legal responsibility, provide, competitors and different dangers); dangers regarding pursuits of our largest shareholders and our Chairman and CEO that differ from our different shareholders; and dangers associated to the event of a brand new manufacturing facility by CASI Wuxi. Such components, amongst others, might have a cloth adversarial impact upon our enterprise, outcomes of operations, and monetary situation. We warning readers to not place undue reliance on any forward-looking statements, which solely converse as of the date made. Further details about the components and dangers that might have an effect on our enterprise, monetary situation, and outcomes of operations, are contained in our filings with the U.S. Securities and Trade Fee, which can be found at

www.sec.gov

.


EVOMELA


®

is

proprietary to Acrotech Biopharma Inc. and its associates.


FOLOTYN® is proprietary to Mundipharma Worldwide Company Restricted and its associates.


COMPANY CONTACT:


Rui Zhang


CASI Prescription drugs, Inc.

Telephone: 240.864.2643

E-mail:

[email protected]


CASI Prescription drugs, Inc.


Unaudited Condensed Consolidated Steadiness Sheets


(In hundreds, besides share and per share knowledge)



June 30, 2023



December 31, 2022


Present belongings:


Money and money equivalents


16,915


47,112


Brief-term investments


19,851


1,462


Funding in fairness securities, at honest worth


2,028


2,763


Accounts receivable


12,529


12,973


Inventories


7,767


6,138


Pay as you go bills and different


1,914


2,975


Complete present belongings


61,004


73,423


Time period deposit, non present




3,065


Property and gear, web


10,122


11,831


Intangible belongings, web


537


1,063


Lengthy-term investments


3,636


4,398


Proper of use belongings


1,368


1,398


Different belongings


1,207


1,056


Complete belongings


77,874


96,234


Present liabilities:


Accounts payable


2,374


3,289


Accrued and different present liabilities


9,533


11,816


Revenue tax payable




1,900


Complete present liabilities


11,907


17,005


Different liabilities


12,124


12,297


Complete liabilities


24,031


29,302


Redeemable noncontrolling curiosity, at redemption worth


21,617


22,358


Shareholders’ fairness:


Atypical shares


1


1


Further paid-in capital


695,224


691,766


Treasury shares


(9,604)


(9,330)


Accrued different complete loss


(1,594)


(703)


Accrued deficit


(651,801)


(637,160)


Complete shareholders’ fairness


32,226


44,574


Complete liabilities, redeemable noncontrolling curiosity and shareholders’ fairness


77,874


96,234


CASI Prescription drugs, Inc.


Unaudited Condensed Consolidated Statements of Operations and Complete Loss


(In hundreds, besides share and per share knowledge)


Three months ended


Six months ended


June 30, 2023


June 30, 2022


June 30, 2023


June 30, 2022


Revenues


Product gross sales


9,820


8,550


18,167


17,575


Lease earnings from a associated celebration




23




60


Complete revenues


9,820


8,573


18,167


17,635


Prices of revenues


3,986


3,550


7,364


7,308


Gross revenue


5,834


5,023


10,803


10,327


Analysis and improvement


2,614


3,851


5,148


7,843


Common and administrative


7,701


5,520


13,446


10,845


Promoting and advertising and marketing


4,820


3,398


8,782


6,675


Overseas alternate loss (acquire)


44


(1,355)


(15)


(1,688)


Complete working expense


15,179


11,414


27,361


23,675


Loss from operations


(9,345)


(6,391)


(16,558)


(13,348)


Curiosity earnings, web


139


40


341


114


Modifications in honest worth of investments


(938)


(1,153)


(1,078)


(2,708)


Different earnings


89


11


1,426


49


Web loss earlier than share of web loss in an fairness investee


(10,055)


(7,493)


(15,869)


(15,893)


Revenue tax expense










Share of web loss in an fairness investee


(15)




(32)




Web loss


(10,070)


(7,493)


(15,901)


(15,893)


Much less: loss attributable to redeemable noncontrolling curiosity


(593)


(548)


(1,260)


(965)


accretion to redeemable noncontrolling curiosity redemption worth


762


735


1,607


1,348


Web loss attributable to CASI Prescription drugs, Inc.


(10,239)


(7,680)


(16,248)


(16,276)


Weighted common variety of peculiar shares excellent (primary and diluted)


13,344,548


13,606,130


13,341,897


13,700,282


Web loss per share (primary and diluted)


(0.77)


(0.56)


(1.22)


(1.19)


Complete loss:


Web loss


(10,070)


(7,493)


(15,901)


(15,893)


Overseas forex translation adjustment


(2,177)


(3,541)


(1,979)


(3,293)


Complete complete loss


(12,247)


(11,034)


(17,880)


(19,186)


Much less: complete loss attributable to redeemable noncontrolling curiosity


(1,789)


(1,800)


(2,348)


(2,144)


Complete loss attributable to peculiar shareholders


(10,458)


(9,234)


(15,532)


(17,042)

Cision
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SOURCE CASI Prescription drugs, Inc.

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