CASI Pharmaceuticals To Present at 2020 Solebury Trout Virtual Investor Conference

ROCKVILLE, Md. and BEIJING, April 7, 2020 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that Dr. Wei-Wu He, Chairman & CEO will present an overview of the company and provide a business update at the Solebury Trout Virtual Global Healthcare Series. During the 25-minute presentation, participants will be able to submit questions electronically with answers provided by the discretion of the company on an individual basis afterwards. Details are as follows:

Date/Time: Tuesday, April 7, at 11:00a.m./p.m. EDT

To access the presentation, please login at: https://78449.themediaframe.com/dataconf/productusers/solebury/mediaframe/36850/indexl.html

Webcast archive: 24 hours following the presentation an archive of the event will be available on the Company’s website at https://www.casipharmaceuticals.com/

CASI Pharmaceuticals Announces Full Year 2019 Financial Results

- Company to host Conference Call Today at 4:30 p.m. ET -
ROCKVILLE, Md. and BEIJING, March 16, 2020 - 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 year ended December 31, 2019, and provided a business update.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, “We made significant progress in 2019 with the August launch of EVOMELA® and ended the year with $4.1 million in revenues. We also in-licensed our other key programs, including CNCT-19 (CD19 CAR-T) and CID-103 (anti-CD38 Mab) strengthening CASI’s position in the hematology/oncology therapeutic area. In 2019, we completed the buildout of our China infrastructure including in the marketing and sales, medical affairs, regulatory and clinical development areas. Despite a slow-down in the first quarter of 2020 due to the coronavirus outbreak (COVID-19), we will continue to drive sales of EVOMELA so that we can fully serve the patients that can benefit from EVOMELA, the only commercially available melphalan in China.”

Dr. He continued, “We are pleased that the CNCT19 (CD19 CAR-T) B-NHL Phase I study is progressing at anticipated pace. Based on previous data, we are excited about the advancement of this very promising therapy, and despite the initial slow-down, we look forward to advancing this study. We remain on track with our other clinical trials planned for 2020.”

Selected Business Highlights

EVOMELA® (melphalan for injection)

In August 2019, the Company launched its first product, EVOMELA (melphalan for injection), in China, marking the transition of CASI to an integrated commercial operation. EVOMELA is unique in that the Captisol®-enabled formulation avoids the use of propylene glycol, which is used as a co-solvent in other forms of melphalan. EVOMELA has greater stability when reconstituted, allowing longer preparation and infusion times, and is currently the only form of melphalan commercially available in China. CASI has built a strong sales and marketing team that is detailing all major hospitals and physicians in the hematology/oncology therapeutic area. CASI intends to continue to drive market awareness and market penetration for EVOMELA in 2020. A post-marketing study for EVOMELA in China is planned for later this year.

CNCT19 (CD19 CAR-T)

In June 2019, CASI acquired exclusive global commercialization rights to CNCT19 (CD19 CAR-T) from Juventas Cell Therapy Ltd., a China-based domestic company specializing in innovative immune cell therapy. CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. Other CD19-targeted CAR constructs from several different institutions have demonstrated antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). Currently, there are no CD-19 CAR-T therapy products marketed in China. CASI intends for CNCT (CD19 CAR-T) to be locally developed and manufactured so that it can be more affordable and widely accessible to patients. The China National Medical Product Administration (NMPA) has approved the clinical trial applications for CNCT19 in B-ALL and B-NHL. CASI expects that the first patient for the B-NHL and B-ALL Phase 1 studies will be dosed in the first half of 2020.

CID-103 (Anti-CD38 Mab)

In April 2019, CASI acquired exclusive global rights to CID-103, a novel anti-CD38 monoclonal antibody program. Preclinical data demonstrate CID-103 to have enhanced activity against a broad array of malignancies which express CD38, and potentially better safety and best in class when compared to other CD38 monoclonal antibodies. CASI expects to file an IMPD/CTA for CID-103 in the first half of 2020, with Phase 1 trials expected to start in the United Kingdom during the second half of 2020.

ZEVALIN® (Ibritumomab Tiuxetan)

In February 2019 the NMPA approved the Company’s clinical trial application for a confirmatory registration trial to evaluate the drug’s efficacy and safety. ZEVALIN is a CD20-directed radiotherapeutic antibody indicated for the treatment of patients with NHL. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90), a beta-emitting radioisotope. CASI intends to advance the development, import drug registration, and market approval of this product in China and is currently in the preparation stage with suppliers. The Company expects the registration study to be initiated by early 2021.

Octreotide Long Acting Injectable (LAI) Microsphere

In November 2019, CASI acquired exclusive China rights for the development and distribution of octreotide long-acting injectable (LAI) microsphere. Octreotide LAI formulations are considered a standard of care for the treatment of acromegaly and the control of symptoms associated with certain neuroendocrine tumors. Octreotide LAI has recently been approved in various European countries. CASI intends to advance the development, import drug registration, and market approval of this product in China, and expects the trial to be initiated later this year.

Thiotepa

The Company recently acquired exclusive China rights for the development and distribution of a novel formulation of thiotepa, a chemotherapeutic agent, which has multiple indications including use as a conditioning treatment for use prior to hematopoietic stem cell transplantation. Thiotepa has a long history of established use in the hematology/oncology setting. CASI intends to advance the development, import drug registration, and market approval of this product in China, and expects the registration study to be initiated by early 2021.

Full Year 2019 Highlights

Product Sales:

Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $4.1 million for the year ended 2019 compared to $0 for the year ended December 31, 2018.

Costs of Revenues:

Costs of revenues were $3.9 million for the year ended December 31, 2019 compared to $0 for the year ended December 31, 2018. The increase is due to the launch of EVOMELA that occurred during August 2019. Costs of revenues have been impacted by a transitional supply agreement that is in the process of being modified with an alternate manufacturer. We expect the unit cost of inventories of EVOMELA to be considerably reduced in the future.

Research and Development Expenses:

Research and development expenses for the year ended December 31, 2019 were $9.7 million, compared with $8.5 million for the year ended December 31, 2018. The increase in R&D expenses primarily reflects higher regulatory costs associated with our ANDAs in 2019, costs incurred with the development of CID-103 and higher consulting and manufacturing related services.

General and Administrative Expenses:

General and administrative expenses for the year ended December 31, 2019 were $27.3 million, compared with $18 million for the year ended December 31, 2018. The increase was related to a combination of factors primarily related to 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 in connection with the commercial 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 CASI’s CEO, President of CASI, and other employees.

Selling and Marketing Expenses:

Selling and marketing expenses for the year ended December 31, 2019 were $3.1 million, compared with $0 for the year ended December 31, 2018. The increase is due to selling costs related to the commercial sales of EVOMELA that began during August 2019.

Acquired In-Process Research and Development:

Acquired in-process R&D expenses for year ended December 31, 2019 were $7.0 million, primarily relating to the acquired Black Belt and Octreotide licenses, compared with $0.7 million for the year ended December 31, 2018, primarily relating to acquired ANDAs in January 2018.

Net Loss:

Net loss for the year ended December 31, 2019 was $45.4 million compared to $27.5 million for the year ended December 31, 2018. The increase is primarily due to the Company’s growth in China to support the Company’s 2019 commercial product launch of EVOMELA, as well as costs associated with the acquired Black Belt and Octreotide licenses.

Cash and Cash Equivalents:

As of December 31, 2019, CASI had cash and cash equivalents of $53.6 million compared to $84.2 million as of December 31, 2018. The decrease in cash is primarily due to the Black Belt and Juventas investments made during the second quarter 2019, along with normal operating expenses.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2019, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the full year 2019 highlights at 4:30 p.m. ET on Monday, March 16, 2020. On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call will be conducted in English, and can be accessed by dialing (833) 647-4459 (U.S.), 8008700181 (China), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5894813.

CASI Pharmaceuticals Enters Exclusive China Distribution License Agreement For Octreotide Long Acting Injectable (LAI) Microsphere For Neuroendocrine Cancers And Acromegaly
ROCKVILLE, Md. and BEIJING, Nov. 7, 2019 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces an exclusive distribution agreement with Pharmathen Global BV for the development and distribution of octreotide long acting injectable (LAI) microsphere in China. Octreotide LAI formulations are considered a standard of care for the treatment of acromegaly and for the control of symptoms associated with certain neuroendocrine tumors. Pharmathen has received regulatory approvals in various European countries. CASI will be responsible for the development, import drug registration and product approval in China and has a long-term exclusive distribution right for the China market after product launch.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer stated, "Octreotide LAI is an asset that we feel enhances and adds value to our growing portfolio of oncology products. Based on historical data, we are confident in the sales projections for octreotide LAI in China as this market has experienced continued growth over the last several years. We believe octreotide LAI will add significant value to patients with neuroendocrine tumors in China which are likely underreported and potentially mistreated. With improvements in diagnostic testing and clinical detection, the number of neuroendocrine tumors diagnosed and treated in China is expected to increase."

About Octreotide

Octreotide is a synthetic peptide which potently mimics the inhibitory activity of the natural hormone somatostatin. Octreotide LAI microsphere is a slow release formulation of octreotide which reduces the need for frequent physician visits and administration, while maintaining the clinical and pharmacological characteristics of the immediate-release formulation of octreotide.

US prescribing and indication details for Octreotide and Octreotide LAI can be found at https://www.fda.gov/

China NMPA Accepts Clinical Trial Application For CASI’s CD19 CAR-T-Product
ROCKVILLE, Md., Sept. 16, 2019 - CASI Pharmaceuticals, Inc. (CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products, announces that the Chinese National Medical Product Administration (NMPA), the Chinese FDA, has accepted the clinical trial application for CNCT19 (CD19 CAR-T) for investigation in relapsed B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). CASI owns the exclusive worldwide license and commercial rights to CNCT19.

Wei-Wu He, Ph.D., CASI’s Chairman and CEO, commented, “CAR-T therapies were first approved in the United States in 2017, and have dramatically improved survival rates for patients suffering from varying B-cell malignancies. The efficacy data generated by the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China, for our CNCT19 technology to date is comparable to the current CAR-T therapies available in the U.S. This drug will be manufactured locally in China at a cost significantly less than the cost of imported therapies from outside of China, ultimately making CNCT19 more widely available to the Chinese patient population. With exclusive global rights, we intend to partner outside of China so that we can similarly make this drug accessible to even more patients.”

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19-targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. CASI holds the worldwide license and commercialization rights to CNCT19. Juventas is responsible for the development of CNCT19 with CASI’s participation on the program’s steering committee.

About Juventas

Juventas Cell Therapy Ltd. is a China-based domestic company located in Tianjin City, China focused on cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma.

CASI Pharmaceuticals Announces First Quarter 2019 Financial and Business Results
- Acquired Exclusive Global Rights to CID-103, a Novel Anti-CD38 Monoclonal Antibody

- Entered into China Distribution Agreement for EVOMELA® (Melphalan Hydrochloride for Injection)

- Received National Medical Products Administration (NMPA) Approval of Clinical Trial Applications (CTAs) for ZEVALIN® (Ibritumomab Tiuxetan) and for MARQIBO® (Vincristine Sulfate Liposome Injection)

- Chairman Wei-Wu He, Ph.D. Expanded Role to Include Chief Executive Officer

ROCKVILLE, Md., May 15, 2019 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, today reported financial results for the first quarter 2019 and provided a review of recent accomplishments and anticipated upcoming milestones.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, “We have made good progress in the first quarter of 2019. Most recently, we announced that we acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103). Preclinical data suggests an enhanced safety and efficacy profile against a broad array of hematological malignancies expressing CD38, making CID-103 an excellent strategic fit amid our broader oncology platform. We look forward to announcing progress in this program as well as across other key programs in our pipeline.”

First Quarter and Recent Business Highlights

Acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody – On April 17, 2019, CASI acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody. CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. It is at the IND/IMPD submission stage of development with Phase 1 trials expected in late 2019 or early 2020. The addition of CID-103 compliments the Company’s oncology pipeline and allows the Company to provide more treatment options to patients in the future.

Entered into distribution agreement with China distribution partner for EVOMELA® (melphalan hydrochloride for injection) – In March 2019, the Company entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd., (CRGK) to be the Company’s exclusive distributor in China for EVOMELA®. CASI will maintain responsibility for direct marketing and sales.

Received National Medical Products Administration (NMPA) Clinical Trial Application (CTA) Approvals – In February and March 2019, CASI announced key NMPA clinical trial approvals (CTA) to conduct confirmatory registration trials for both ZEVALIN® and MARQIBO®, respectively. ZEVALIN® is indicated for relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma and MARQIBO® is indicated for Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. The Company is working toward getting the trials started in China.

Chairman Wei-Wu He, Ph.D. expanded role to include Chief Executive Officer – On April 2, 2019, CASI appointed its Chairman of the Board of Directors as the Company’s Chief Executive Officer. Dr. He served on CASI’s Board of Directors since 2012. Dr. He has a very successful career building companies from early stage to revenue and profitability stages and most recently was the CEO of OriGene Technologies which he co-founded and built into a profitable life science company; OriGene ultimately merged with a publicly traded Chinese company in 2018.

Financial Results for the Quarter ended March 31, 2019

Cash Position: As of March 31, 2019, CASI had cash and cash equivalents of $99.7 million.

R&D Expenses: R&D expenses for the quarter ended March 31, 2019 were $2.6 million compared to $1.7 million in 2018, an increase of $0.9 million. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, primarily associated with our acquired ANDAs in 2018, as well as an increase in facility costs due to new lease space in China, as well as an increase in personnel costs due to growth in the number of employees.

G&A Expenses: G&A expenses for the quarter ended March 31, 2019 were $5.7 million compared to $1.3 million in 2018. The increase of $4.4 million in G&A over the prior year primarily reflects an increase of $1.6 million in non-cash stock compensation expense largely attributed to stock options issued to the Company’s Chairman and also the President of CASI China, an increase in salary, benefits and recruitment expense, as well as facilities costs primarily in China, related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with professional services fees, including audit and legal services during the 2019 period.

Net Loss: The Company reported a net loss of ($8.2 million), or ($0.09) per share, for the quarter ended March 31, 2019. This compares with a net loss of ($3.6 million), or ($0.05) per share for the first quarter of 2018. The larger net loss for both periods is primarily due to the increase in non-cash stock-based compensation expense during the 2019 period, costs associated with the manufacturing and regulatory support for our ANDA portfolio, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, as well as increased facilities cost in China and higher professional service fees.

CASI Pharmaceuticals In-Licenses Exclusive Worldwide Rights to Novel Anti-CD38 Monoclonal Antibody Program From Black Belt Therapeutics
ROCKVILLE, Md., April 17, 2019 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, announces the signing of a license agreement for exclusive worldwide rights to the investigational anti-CD38 monoclonal antibody (Mab) TSK011010 program from Black Belt Therapeutics Limited.

Under the terms of the agreement, CASI has obtained global rights to TSK011010 for an upfront payment of 5 million euros and an equity investment of 2 million euros, as well as certain milestone and royalty payments. The equity investment will be made in a newly established company of Black Belt Therapeutics focusing on novel immuno-oncology targets. CASI will be responsible for all development and commercialization activities of the TSK011010 program.

TSK011010 is at the IND/IMPD submission stage of development, with Phase 1 trials expected to start in late 2019/early 2020. Preclinical data demonstrate TSK011010 to have enhanced activity against a broad array of malignancies which express CD38 and potentially better safety when compared to other CD38 Mabs.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "This license agreement for TSK011010 is very exciting because based on preclinical data, we believe this molecule has the potential to be best in class and will hopefully translate into meaningful clinical benefits for patients with CD38 malignancies, including multiple myeloma. The addition of TSK011010 to our portfolio provides CASI the opportunity to offer a range of therapeutic options for the treatment of hematologic malignancies."

Alexander Zukiwski, M.D., CASI's Chief Medical Officer commented, "The preclinical data for TSK011010 targeting multiple myeloma has shown impressive results thus far and seems to outperform other anti-CD38 Mabs. We are enthusiastic and look forward to the clinical development for this novel biological entity as a potential treatment for patients with hematological malignancies, such as multiple myeloma."

About CD-38 Mab TSK011010

Anti-CD38 Mab TSK011010 is a fully human IgG1 monoclonal antibody that recognizes a unique epitope on CD38. It has demonstrated potent CD38+ cell killing, and was designed to directly activate effector T cells and NK cells. In preclinical studies it has demonstrated immune effector mechanisms with strong antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and complement-dependent cytotoxicity (CDC) activity. GLP IND-enabling studies have been completed and IND/IMPD submissions are planned for 2019.

CASI Pharmaceuticals Announces The Appointment Of Wei-Wu He, Ph.D., Executive Chairman, To The Role Of Chief Executive Officer
ROCKVILLE, Md., April 2, 2019 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world, announced that Wei-Wu He, Ph.D., Executive Chairman of CASI, has been appointed Chief Executive Officer. Dr. He will continue to serve as Chairman of the Board of Directors. Dr. He succeeds Ken K. Ren, Ph.D. who for personal reasons is stepping down from his role as Chief Executive Officer but will remain on the Company's Board of Directors.

Prior to joining CASI as CEO, Dr. He had a very successful career building companies from early to revenue and profit stages. Most recent from his track record was serving as CEO of OriGene Technologies, Inc., which he co-founded and built into a profitable life science company that later merged with a publicly traded Chinese company, VICANBIO Cell & Gene Engineering Corp., Ltd. (SHA: 600645). Dr. He will continue in his role as Chairman of the Board of OriGene, and is also the founder and general partner of Emerging Technology Partners, LLC, a life sciences focused venture fund, and has been involved in funding over 60 biotech companies. In the earlier part of his career, Dr. He was one of the first few scientists at Human Genome Sciences, and prior to that, was a research fellow at Massachusetts General Hospital and Mayo Clinic. Dr. He is an author to 30 research publications and holder of over 32 issued patents.

"We are grateful for Ken's dedication to CASI during the Company's transition period and his role in the Company's growth in China, the advancement of our pipeline and our fundraising initiatives," said Dr. He.

Dr. He continued, "This is an exciting inflection point in CASI's history and I look forward to working with our management team to build a revenue-driven commercial company, with EVOMELA® as the first product in our pipeline to launch this year. I am particularly excited to pursue additional products to complement our pipeline and therapeutic areas, while we concurrently advance our existing products to the market and serve our patients."

CASI Pharmaceuticals Announces Fourth Quarter And Full Year 2018 Financial Results And Business Results
- Announced distribution partner for Melphalan Hydrochloride for Injection (EVOMELA®) to support commercialization in China following NMPA approval in December of 2018

- Announced NMPA approval of CTAs to conduct confirmatory registration trials for vincristine sulfate LIPOSOME injection (MARQIBO®) and Ibritumomab Tiuxetan (ZEVALIN®)

- Announced plans to build GMP manufacturing site in Wuxi, China

- Announced acquisition of ANDA for HBV from Laurus Labs

- Announced key new hires to support global commercialization efforts

ROCKVILLE, Md., March 29, 2019 -CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world, today reported financial results for the fourth quarter and year ended December 31, 2018 and provided a review of recent accomplishments and anticipated upcoming milestones.

Wei-Wu He, Ph.D., Executive Chairman of CASI Pharmaceuticals, commented, "The fourth quarter of 2018 capped a successful year for CASI with the NMPA marketing approval of EVOMELA, which is used as a conditioning treatment prior to stem cell transplantation and offers palliative treatment for multiple myeloma patients for whom oral therapy is not appropriate. Our commercialization team is laying the ground work to prepare for its launch in China which we anticipate will commence in mid-2019."

Dr. He continued, "We kicked off the first quarter of 2019 with the NMPA's Clinical Trial Application (CTA) approval of confirmatory registration trials for both ZEVALIN, a CD20-directed radiotherapeutic antibody primarily indicated for patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma, and MARQIBO, a formulation of vincristine sulfate for the treatment of patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia.

Chinese patients suffering from these three distinct hematology oncology malignancies currently have limited therapeutic alternatives available to them; we aim to make each of these products broadly accessible for patients and will continue strategically evaluating additional U.S. FDA-approved products that potentially complement our burgeoning hematology oncology portfolio in China. To further that end, we established CASI Pharmaceuticals (Wuxi) Co. Ltd. in order to build a GMP manufacturing plant in Wuxi, China which is scheduled to break ground in 2019. We look forward to advancing our pipeline, including the selected products in our ANDA portfolio, and expect to further expand our pipeline through in-licensing and acquisitions."

Full Year and Recent Business Highlights

Announced exclusive distribution partnership for the distribution of melphalan hydrochloride for injection (EVOMELA) in China – In March 2019, efforts to ramp up EVOMELA's launch in China prompted the announcement that China Resources Guokang Pharmaceuticals Co., Ltd. (CRGK) will be the Company's sole distributor in China. The Company will maintain responsibility for direct marketing and sales. EVOMELA will be used in the treatment of multiple myeloma patients in China where there is currently no form of melphalan available to patients. The distribution agreement comes on the heels of the NMPA's marketing approval for EVOMELA previously announced in December 2018.
Announced NPMA marketing approval of EVOMELA – In December 2018, the Company announced the NMPA's marketing approval of EVOMELA. This is the first of CASI's pipeline assets to be approved under the NMPA's priority review guidelines which accelerates approval for medicines that meet certain requirements identified by the Agency. The Company will conduct a post-marketing trial. In the case of EVOMELA, NMPA's priority review and approval was granted to CASI because there is currently no form of melphalan available in China to treat multiple myeloma patients.
Announced NMPA approval of CTAs to conduct confirmatory registration trials for ibritumomab tiuxetan (ZEVALIN) and vincristine sulfate LIPOSOME injection (MARQIBO) – In February and March 2019, the Company announced NMPA approvals of CASI's clinical trial applications (CTA) to conduct confirmatory registration trials for ZEVALIN and MARQIBO, respectively. ZEVALIN is indicated for relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma and MARQIBO is indicated for Philadelphia chromosome-negative (Ph?) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
Announced plans to build GMP manufacturing site in Wuxi, China – In November 2018, the Company announced that it established CASI Pharmaceuticals (Wuxi) Co., Ltd. to build its own GMP manufacturing site in Wuxi, China. The site is strategically located in The Wuxi Huishan Economic Development Zone which is a leading science and technology innovation center in the region. The Company plans to break ground this year.
Announced acquisition of an additional HBV ANDA from Laurus Labs to build HBV therapeutic specialty – In October 2018, CASI announced that it acquired tenofovir disoproxil fumarate (TDF) which is indicated for the treatment of hepatitis B virus (HBV).
Announced key new hires for China and U.S. operations – In 2018, the Company announced key new hires to both CASI locations in Beijing, China and Rockville, MD, U.S.A. in order to support the Company as it continues to grow and commercialize. In September the Company appointed George Chi, CPA, CFA, as CASI's Chief Financial Officer, and in October, the Company appointed Larry Zhang as President of CASI (Beijing) Pharmaceuticals Co., Ltd., the Company's operating subsidiary in China.
Fourth Quarter and Full Year 2018 Financial Highlights

R&D Expenses:
Research and development (R&D) expenses for the year ended December 31, 2018 were $8.5 million compared to $7.6 million in 2017, an increase of $0.9 million. The increase in 2018 reflects a $1.1 million increase in regulatory related services, primarily associated with our acquired ANDAs in 2018; a $1.3 million increase in amortization expense due to ANDAs acquired in 2018; and a $1.0 million increase in personnel costs due to new employees hired in 2018, offset by $2.7 million in higher costs associated with the quality testing phase of the NMPA regulatory review of ZEVALIN and EVOMELA in 2017.

R&D expenses for the quarter ended December 31, 2018 were $3.3 million compared to $3.8 million in 2017, a decrease of $0.5 million. The decrease in R&D expenses primarily reflects $2.3 million in higher costs associated with the quality testing phase of the NMPA regulatory review of ZEVALIN and EVOMELA in 2017, offset by $0.8 million higher regulatory services associated with our acquired ANDAs in 2018, $0.5 million more of personnel costs, and $0.4 million amortization expense associated with our ANDAs acquired in 2018.

G&A Expenses:
General and administrative (G&A) expenses for the year ended December 31, 2018 were $18.0 million compared to $3.2 million in 2017. The increase of $14.8 million in G&A over the prior year primarily reflects an increase of $5.0 million in non-cash stock compensation expense largely attributed to stock options issued to the Company's Executive Chairman, an increase in salary, benefits and recruitment expense in China, primarily related to sales and marketing efforts to prepare for the anticipated launch of the Company's first commercial product in China, as well as other G&A functions. There were also increased costs associated with business development related to exploratory acquisition activities, investor and public relations activities, and an increase in legal and other professional services fees during 2018.

G&A expenses for the quarter ended December 31, 2018 were $5.8 million compared to $1.2 million in 2017. The increase in G&A over the prior period primarily reflects the increase in non-cash stock compensation expense of $2.0 million, an increase in personnel costs, primarily in China, and increases in consulting and professional services fees during the 2018 period.

Net Loss:
The net loss for the year ended December 31, 2018 was ($27.5 million), or ($0.32) per share, compared with a net loss of ($10.8 million) or ($0.18) per share in 2017. The larger net loss for both periods is primarily due to the non-cash stock-based compensation expense for stock options issued during 2018, costs associated with the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million in January 2018 due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development related to exploratory acquisition efforts and investor relations activities, higher professional service fees, and administrative fees associated with the Company's September 2018 financing.

The Company reported a net loss of ($9.3 million), or ($0.1) per share, for the quarter ended December 31, 2018. This compares with a net loss of ($5.0 million), or ($0.08) per share for the fourth quarter of 2017. The increase in net loss is primarily due to increases in non-cash stock compensation expense, personnel costs, and consulting and professional fees during the 2018 period compared to the 2017 period.

As of December 31, 2018, CASI had cash and cash equivalents of approximately $84.2 million.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2018, can be found at www.casipharmaceuticals.com.

CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Registration Trial For MARQIBO®
ROCKVILLE, Md., March 7, 2019 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. based pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world, announced that the National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) allowing for a registration clinical trial to evaluate the efficacy and safety of vincristine sulfate LIPOSOME injection (MARQIBO®).

MARQIBO® is a U.S. Food and Drug Administration (FDA)-approved product currently marketed in the U.S. by Spectrum Pharmaceuticals, Inc. (Spectrum), for the treatment of adult patients with Philadelphia chromosome–negative (Ph?) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. CASI acquired greater China rights to this drug from Spectrum.

The Company is currently reviewing certain requirements provided by the Center for Drug Evaluation (CDE), a division of the NMPA, and upon satisfying those requirements, the Company will commence the registration trial for MARQIBO®.

Wei-Wu He, Ph.D., CASI's Executive Chairman commented, "Ph negative ALL is a rare but aggressive disease and while patient outcomes have vastly improved over the last three decades, patients continue to relapse and current salvage therapies are inadequate, particularly among the aging Chinese patient population. MARQIBO® is the first and only liposome-encapsulated vincristine approved and marketed in the U.S. for second line treatment of adult Philadelphiachromosome-negative acute lymphoblastic leukemia and has been safely administered in patients since its U.S. approval in 2012. Receiving NMPA approval to conduct the registration trial in China with MARQIBO® is an important milestone for CASI. This approval, along with the recent CTA approval for ZEVALIN® and the fast track market approval of EVOMELA®, further demonstrates CASI's regulatory strength in working with the NMPA to advance products through the approval process."

CASI Pharmaceuticals Announces China Market Approval Of Melphalan Hydrochloride For Injection (Trademark: EVOMELA®)

National Medical Products Administration Approves Melphalan Hydrochloride For Injection (EVOMELA®) as Treatment for Specific Uses in Patients with Multiple Myeloma
ROCKVILLE, Md., Dec. 3, 2018 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in China and throughout the world, announces today that it has received National Medical Products Administration ("NMPA") (formerly, the China FDA) approval of Melphalan Hydrochloride For Injection (EVOMELA®), for:

use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and
the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
The NMPA approved Melphalan Hydrochloride For Injection (EVOMELA®) under its new priority review guidelines. The NMPA's Expert Advisory Anti-Tumor (Oncology) Drugs Committee previously had reviewed Melphalan Hydrochloride For Injection (EVOMELA®) in April, 2018. The NMPA approval of Melphalan Hydrochloride For Injection (EVOMELA®) Melphalan Hydrochloride For Injection (EVOMELA®) for use in patients with multiple myeloma was based on an existing safety and efficacy data base; the NMPA required no additional pre-approval clinical studies, but requires a post approval confirmatory study.

CASI Pharmaceuticals Executive Chairman Wei-Wu He, Ph.D., commented, "NMPA approval of Melphalan Hydrochloride For Injection (EVOMELA®) is encouraging news for patients in China with multiple myeloma as there is no commercially available melphalan formulation in the country. EVOMELA's approval therefore addresses a significant unmet medical need. In addition, EVOMELA®'s proprietary formulation of melphalan, a first-line therapy for multiple myeloma patients, offers considerable clinical advantages as it does not contain propylene glycol, which may cause side effects, it has long stability when reconstituted for infusion, and is the only intravenous melphalan product approved for use in the high-dose conditioning indication in pre-transplant therapy."

Dr. He continued, "CASI will continue to rapidly build out its commercial operations and we are working to launch Melphalan Hydrochloride For Injection (EVOMELA®) in China promptly to meet the needs of patients suffering from this devastating disease. With the approval of Melphalan Hydrochloride For Injection (EVOMELA®), CASI becomes an integrated commercial-stage company; we will continue working tirelessly to address varying unmet medical needs within China and throughout the world.."

About Multiple Myeloma

Multiple myeloma is a malignant hematological disorder that is characterized by abnormal proliferation of clonal plasma cells in the bone marrow and the secretion of monoclonal immunoglobulins that are detectable in the serum or urine. Multiple myeloma accounts for 10-13% of hematological malignancies1,2 and in Western countries, the estimated incidence is 5.6 cases per 100,000 persons2. The estimated incidence of multiple myeloma in China is ~2.0 cases per 100,000 persons3, for an estimated annual incidence of approximately 27,8003. The estimated number of patients in China with multiple myeloma who are candidates for hematopoietic progenitor (stem) cell transplantation is estimated to be approximately 16,900/year. The current number of patients with multiple myeloma who undergo hematopoietic progenitor (stem) cell transplantation in China is estimated to be approximately 800/year. Autologous stem cell transplantation (ASCT) has been demonstrated to improve complete response rates and prolong median overall survival in patients with multiple myeloma1,3 and is considered standard of care for transplant-eligible patients. The preferred conditioning regimen for ASCT is melphalan1.

1. S. Rajkumar, Mayo Clin Proc. 2016 January; 91(1): 101–119

2. A. Palumbo, N Engl J Med, 2011; 364: 1046-60

3. J. Lu, Blood Cancer Journal (2014) 4, e239; doi:10.1038/bcj.2014.55

4. L. Xu, Bone Marrow Transplantation (2017), 1 – 7

CASI Pharmaceuticals Announces $48.5 Million Private Placement
ROCKVILLE, Md. (September 14, 2018) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces today a $48.5 million private placement. The Company has entered into definitive securities purchase agreements pursuant to which the Company will issue 9,048,504 shares of its Common Stock with accompanying warrants to purchase 2,714,548 shares of its Common Stock. The purchase price for each share of Common Stock and warrant is $5.36. The warrants will become exercisable 180 days after issuance at a $7.19 per share exercise price, and will expire three years from the date of issuance.

The financing was led by new and returning investors and is expected to close on or about September 21, 2018. CASI intends to use the net proceeds from the offering principally to support commercial activities, ongoing business development activities, and for general working capital purposes.

The offering of shares of Common Stock and warrants has not been registered under the Securities Act of 1933, as amended (the “Securities Act”) or any state securities laws, and the shares are being offered pursuant to an exemption from registration and in reliance on similar exemptions under applicable state laws. The investors will receive certain registration rights in connection with the offering.

Wei-Wu He, Ph.D., CASI’s Executive Chairman commented, “This financing places us in a strong position to continue our pursuit of strategic pipeline expansion as part of our mission to bring innovative and high-quality medicines to market. Our broad and evolving platform, including our in-licensed products, EVOMELA®, MARQIBO® and ZEVALIN®, for the greater China region, are all currently in various regulatory stages for market approval in China, with EVOMELA® under priority review, along with our portfolio of 29 abbreviated new drug applications (ANDAs) (including 25 FDA-approved and 4 pending approval).”

CASI Pharmaceuticals Announces Second Quarter And First Half 2018 Financial And Business Results
- China FDA (CFDA) import drug registration priority review of EVOMELA® in progress and preparations continue for its commercial launch in China
- CFDA review in progress for Marqibo® and Zevalin®
- Entered into an agreement for the manufacturing of entecavir and cilostazol
- Added to Russell 2000®, 3000® andMicrocap® Indexes

ROCKVILLE, Md., Aug. 14, 2018 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, today reported financial results for the second quarter and six months ended June 30, 2018 and provided a review of recent accomplishments and anticipated upcoming milestones.

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, “Our financial results for the second quarter of 2018 are in line with our expectations. We have made tremendous progress since the start of 2018 and remain committed to working with the relevant regulatory authorities and our strategic partners in the U.S. and in China to provide high quality, life-saving medications to patients. We will continue to advance our current product portfolio while evaluating additional opportunities to add further medicines to our pipeline.”

Second Quarter and Recent Business Highlights

China FDA (CFDA) import drug registration priority review of EVOMELA® in progress – On April 26, 2018, the Center for Drug Evaluation (CDE) of the China FDA held a Clinical Advisory Committee (the “Advisory Committee”) meeting to review the EVOMELA application. CASI has recently received a series of standard questions from the CFDA related to EVOMELA drug product production which usually reflect the final stage of CFDA assessment before approval based on the Import Drug Approval registration pathway. CASI is working with Spectrum Pharmaceuticals and its vendors from whom EVOMELA is in-licensed to address the questions and submit the requested documents.

Preparation continues for EVOMELA®‘s commercial launch in China – CASI is building an in-house marketing and sales team with key members in place. The team is led by Thomas Zhang who has a 20-year track record of commercialization of multiple anti-cancer drugs in China for companies such as Roche and Johnson & Johnson.

CFDA review in progress for Marqibo® and Zevalin® – CASI continues to work with the CFDA on advancing Marqibo’s import drug clinical trial application and anticipates that the regulatory agency will complete its review within the next four to six months. The import drug clinical trial application for ZEVALIN is also in process with CFDA. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the application require separate submissions of which both are currently under technical review by the CDE of CFDA and the quality confirmatory testing by National Institute for Food and Drug Control (NIFDC) of CFDA as part of the regulatory review process.

Company enters into strategic manufacturing agreement – In June 2018, CASI entered into a strategic and long-term contracting manufacturing agreement for the manufacturing of entecavir and cilostazol. The partnership will support CASI’s plan to market and sell both products in China, U.S. and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that were acquired from Sandoz in January 2018.

CASI added to Russell 2000®, 3000® and Microcap® Indexes – In July 2018, CASI announced that the company has been added to the Russell 2000®, 3000® and Microcap® Indexes.

Second Quarter and First Half 2018 Financial Results

Cash Position: As of June 30, 2018, CASI had cash and cash equivalents of $66.2 million compared to $49.9 million as of March 31, 2018. This increase primarily reflects the remaining gross proceeds of $20.7 million received in April 2018 related to CASI’s $50 million private placement announced in March 2018, partially offset by costs related to operating expenses during the quarter.

R&D Expenses: Research and development (R&D) expenses for the three and six months ended June 30, 2018, were $1.7 million and $3.4 million, respectively, compared to $1.7 million and $2.8 million for the same periods in 2017. The increase in R&D expenses primarily reflects personnel costs associated with the technology transfer activities and regulatory support associated with the recently acquired ANDA portfolio, offset by a decrease in costs related to the timing of the CFDA regulatory process of CASI’s in-licensed U.S. FDA approved assets from Spectrum Pharmaceuticals.

G&A Expenses: General and administrative (G&A) expenses for the three and six months ended June 30, 2018, were $4.0 million and $5.3 million, respectively, compared to $0.7 million and $1.3 million for the same periods in 2017. The increase in G&A over the prior year is primarily attributed to non-cash stock-based compensation expense for the stock options issued to the Company’s Executive Chairman and an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with business development related to exploratory acquisition activities, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period. G&A expenses include non-cash stock-based compensation of $1.5 million and $1.6 million for the three and six months ended June 30, 2018, respectively, compared to $0.1 million and $0.2 million in the respective periods in 2017.

Net Loss: The Company reported a net loss attributable to common shareholders for the three and six months ended June 30, 2018 of ($5.9) million, or ($0.07) per share, and ($9.5) million, or ($0.12)per share, respectively, compared to ($2.4) million, or ($0.04) per share, and ($4.1) million, or ($0.07)per share for the same periods in 2017. The larger net loss is primarily due to the non-cash stock-based compensation expense for stock options issued to the Company’s Executive Chairman, costs associated with the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million in January 2018 due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development and investor relations activities, as well as other professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, can be found at www.casipharmaceuticals.com.

About CASI Pharmaceuticals, Inc.

CASI Pharmaceuticals (NASDAQ: CASI) is a U.S.-based biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world. CASI’s product pipeline features three U.S. Food and Drug Administration (FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights. These are currently in various stages in the regulatory process for market approval in China. The Company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs that are pending FDA approval. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.

CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces a strategic and long-term manufacturing agreement with Yiling Wanzhou International Pharmaceutical Co., Ltd. for the manufacturing of entecavir and cilostazol. Yiling Wanzhou International Pharmaceutical Co., Ltd. is a subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd. The contracted manufacturing facilities have been inspected by both the U.S. Food and Drug Administration (FDA) and China FDA (CFDA) and operate to strict International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Manufacturing Practice (GMP) standards, which will enable CASI to eventually sell both entecavir and cilostazol in the U.S., China and worldwide markets. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that CASI acquired from Sandoz in January 2018.

CASI Pharmaceuticals logo (PRNewsFoto/CASI Pharmaceuticals, Inc.)

Ken K. Ren, Ph.D., CASI's Chief Executive Officer stated, "We are very pleased to partner with Yiling Wanzhou International as our manufacturing site for entecavir and cilostazol. Through this partnership, we will leverage Yiling's manufacturing knowledge and capabilities in order to provide high quality, cost-effective medicines that are critically needed for patients both in China and the U.S."

Dr. Ren continued, "This partnership further supports the overarching vision of CASI to bring much needed medicines from the U.S. into China as well as cost-effective drugs from China to the U.S. This would also be the first step for CASI to execute on our overall development plan for the acquired ANDAs with additional development activities and partnering discussions underway."

The FDA approved entecavir in 2005 for the treatment of chronic hepatitis B viral (HBV) infection.1 Entecavir is an HBV nucleoside analog reverse transcription inhibitor that interferes with HBV replication. There are over 100 million HBV carriers in China with approximately 20 million people with chronic HBV infection. The 2016 estimated sales in China for entecavir were approximately $1.5 billion USD, which accounted for approximately 20-percent of the patients with chronic HBV receiving entecavir treatment.

The FDA approved cilostazol in 2006 for the reduction of symptoms of intermittent claudication.2 Cilostazol is a PDE-III inhibitor. Cilostazol inhibits platelet aggregation, improves endothelial cell function, and acts as a vasodilator enabling blood to move more easily through peripheral blood vessels. The 2016 estimated sales in China for cilostazol were approximately $65 million USD.

CASI Pharmaceuticals To Present At The BIO International Convention
 
ROCKVILLE, Md., May 29, 2018 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces it will present at the BIO International Convention, June 4-7, 2018 in Boston, MA.

Presentation details are below:

Event: BIO International Convention 
Date: Monday, June 4, 2018 
Time: 3:30 P.M.
Presenter: James E. Goldschmidt Ph.D., Senior Vice President, Business Development
Presentation Room: Theater 4

A copy of the presentation materials will be made available directly through the Investor Relations section of the company’s website, www.casipharmaceuticals.com, following the presentation.

COMPANY CONTACT:

CASI Pharmaceuticals, Inc.

240.864.2643

ir@casipharmaceuticals.com

INVESTOR CONTACT:

Solebury Trout

Jennifer Porcelli

646.378.2962

jporcelli@troutgroup.com



Brennan Doyle

617.221.9005

BDoyle@troutgroup.com

MEDIA CONTACT:

PressComm PR, LLC

Jamie Lacey-Moreira

410.299.3310

jamielace

CASI PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2018 FINANCIAL AND BUSINESS RESULTS
- Preparations for EVOMELA® commercial launch in China underway, including hiring of the General Manager of Sales & Marketing

- Chinese FDA (CFDA) Expert Advisory Committee meeting for EVOMELA® occurred on April 26, 2018; formal feedback regarding next steps in the accelerated regulatory process anticipated in the coming weeks

- Acquired portfolio of 25 US FDA-approved abbreviated new drug applications (ANDAs) from Sandoz Inc.

- $50 million capital raise in Q1 2018 to support CASI’s product and business advancement

ROCKVILLE, Md., May 15, 2018 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, today reported financial results for the first quarter and provided a review of recent accomplishments and anticipated upcoming milestones.

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, commented, “We have made significant progress in 2018, having acquired a portfolio of 25 US FDA-approved ANDAs from Sandoz, which has substantially broadened our product pipeline. The acquisition squarely enhances our strategic focus of capitalizing on the evolving CFDA landscape, which is expected to streamline and accelerate the approval process for high-quality generic products.”

Dr. Ren continued, “The capital raise announced in March leaves us well-positioned to drive forward with our EVOMELA®commercialization plans, and given the positive tenor of the April 2018 Center for Drug Evaluation (CDE) Expert Advisory Committee meeting, where no questions were posed and no new materials were requested, we remain encouraged that we will receive additional feedback from the CDE/CFDA regarding the EVOMELA® application in the coming weeks. We remain committed to developing a strong and robust product portfolio through licensing opportunities as well as seeking other advantageous relationships that will further expand our footprint in both the U.S. and in China.”

First Quarter and Recent Business Highlights

Company prepares for commercial launch of EVOMELA® in China – In March 2018, CASI hired Thomas Zhang as General Manager of its Sales & Marketing team in China and is currently building out a robust and experienced team in China to support commercial operations there. Mr. Zhang has over 20 years of commercial experience in China, and prior to joining CASI was responsible for the successful launch and commercialization of Herceptin® and Xeloda® at Shanghai Roche Pharmaceuticals Co., Ltd. A team of seasoned sales and marketing professionals are being hired in preparation for the launch of EVOMELA® following anticipated marketing authorization.

Update on advisory committee meeting notice from China Center for Drug Evaluation (CDE) - On April 26, 2018, the Center for Drug Evaluation (CDE), a group within the China FDA in charge of technical review, held a meeting of the Expert Advisory Anti-Tumor (Oncology) Drugs Committee (the “Advisory Committee”) to review the EVOMELA®application. In preparation for the Advisory Committee meeting, no additional questions were posed and the CDE requested no new analysis or materials. The Advisory Committee meeting did not include sponsor or public participants and the Advisory Committee will provide its recommendations directly to the CDE. CASI anticipates receiving feedback from the CDE/CFDA on the EVOMELA® application in the coming weeks.

Acquired portfolio of 25 US FDA-approved ANDAs from Sandoz Inc. - In January 2018, the Company announced the acquisition of a portfolio of 25 US FDA-approved ANDAs, plus four pipeline ANDA’s that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that have a unique market opportunity and cost-effective manufacturing in China and/or in the U.S.

Announced $50 million private placement to new and existing investors - In March 2018, the Company announced a $50 million private placement (common stock with accompanying warrants). Existing stockholders or their affiliates, including IDG-Accel China Growth Fund III, ETP Global Fund LP, and new stockholders including Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc., led the financing.

Upcoming presentations - CASI will provide a corporate update at the 2018 BIO International Convention (Boston, MAJune 4-7).

Financial Results for the Quarter ended March 31, 2018

Cash Position: As of March 31, 2018, CASI had cash and cash equivalents of $49.9 million.

R&D Expenses: R&D expenses for the quarter ended March 31, 2018 were $1.7 million compared to $1.0 million in 2017, an increase of $0.7 million. The increase in R&D expenses primarily reflects costs associated with the technology transfer activities and regulatory support associated with the recently acquired ANDA portfolio, including non-cash intangible amortization expense of $0.3 million.

G&A Expenses: G&A expenses for the quarter ended March 31, 2018 were $1.3 million compared to $0.6 million in 2017. The increase in G&A over the prior year is primarily attributed to an increase in salary, benefits and recruitment expense in China, largely related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other general and administrative functions. There were also increased costs associated with business development, investor and public relations activities, and an increase in legal and other professional services fees during the 2018 period.

Net Loss: The Company reported a net loss of ($3.6 million), or ($0.05) per share, for the quarter ended March 31, 2018. This compares with a net loss of ($1.7 million), or ($0.03) per share for the first quarter of 2017. The increase in net loss is primarily due to costs associated the technology transfer activities and regulatory support for our ANDA portfolio, the write-off of approximately $0.7 million due to acquired in-process R&D primarily related to ANDAs not approved by the FDA, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, increased business development and investor relations activities, as well as other professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, can be found at www.casipharmaceuticals.com.

About CASI Pharmaceuticals, Inc.

CASI Pharmaceuticals (NASDAQ: CASI) is a U.S.-based biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., Chinaand throughout the world. CASI’s product pipeline features three U.S. Food and Drug Administration (FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights. These are currently in various stages in the regulatory process for market approval in China. The Company also acquired a portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs that are pending FDA approval. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, 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: risks relating to interests of our largest stockholders that differ from our other stockholders; the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our recently acquired portfolio of abbreviated new drug applications (ANDAs); 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 China Food and Drug Administration authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage products under development; risk that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; and our dependence on third parties. 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 Spectrum Pharmaceuticals, Inc. and its affiliates.
Herceptin® and Xeloda® are proprietary to F. Hoffman La Roche Ltd. and its affiliates.
(Financial Table Follows)

COMPANY CONTACT: INVESTOR CONTACT: MEDIA CONTACT:
CASI Pharmaceuticals, Inc. Solebury Trout PressComm PR, LLC
240.864.2643 Jennifer Porcelli Jamie Lacey-Moreira
ir@casipharmaceuticals.com 646.378.2962 410.299.3310
jporcelli@troutgroup.com jamielacey@presscommpr.com

Brennan Doyle
617 221 9005
BDoyle@troutgroup.com







(basic and diluted)
diluted)

CASI Pharmaceuticals, Inc.
SUMMARY OF OPERATING RESULTS

Three Months Ended March 31,

2018 2017
Total Revenues $ - $ -

Research & development $ 1,697,232 $ 1,049,287

General & administrative $ 1,303,122 $ 644,163

Acquired in-process research and development $ 686,998 $ -

Net loss $(3,590,910) $(1,700,182)

Net loss per share attributable to common shareholders $ (0.05) $ (0.03)

Weight average number of shares outstanding (basic and 71,215,000 60,196,574

Cash and cash equivalents $49,887,600 $25,528,952

CASI PHARMACEUTICALS PROVIDES UPDATE ON EVOMELA®
CASI Receives Advisory Meeting Notice from China Center for Drug Evaluation

ROCKVILLE, Md. (April 5, 2018) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, announces receipt of a letter from the Center for Drug Evaluation (CDE) (group within the China FDA in charge of technical review) indicating that EVOMELA® (melphalan) for injection has been scheduled for review by the Expert Advisory Anti-Tumor (Oncology) Drugs Committee (the “Advisory Committee”), which is scheduled to take place between April 25-26, 2018 (the “Advisory Committee Meeting”).

The Advisory Committee Meeting is a closed meeting. No additional information on the EVOMELA® application has been requested by the CDE in advance of the Advisory Committee Meeting, however, CASI will submit a Clinical Data Briefing Package which will summarize the various components contained in the previously submitted application.

EVOMELA® was accepted under CFDA’s new guidelines for priority review and the review by the Advisory Committee was expected as part of the recently implemented CFDA reforms. CASI anticipates that after the Advisory Committee Meeting, the Advisory Committee will make a recommendation to CDE, followed by CDE recommendation to CFDA, and CFDA notification of review status to CASI.

As reported previously, the September 2017 CFDA letter provided the following reasons for granting priority review of EVOMELA®:

EVOMELA® is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China;
There is no melphalan in any formulation available in China to address this unmet medical need;
EVOMELA® has clear therapeutic advantage to currently available therapeutics.
Wei-Wu He, Ph.D., CASI Pharmaceuticals Executive Chairman, commented, “Receiving notice from CDE regarding the Advisory Committee Meeting is very exciting news. This indicates the completion of the CDE’s initial review of the EVOMELA® NDA package and referral to the panel of independent experts is the next step in the review process. Multiple myeloma is the second most common hematological malignancy which often occurs in elderly patients. The Advisory Committee review of the EVOMELA® application marks a significant milestone toward addressing an unmet medical need for patients with multiple myeloma in China, as there are no versions of melphalan commercially available. EVOMELA®’s innovative and proprietary new formulation of melphalan offers significant advantages in that it does not contain propylene glycol which causes significant side effects, has long stability and is the only intravenous melphalan product approved for use in the high-dose conditioning indication in pre- transplant therapy”.

About CASI Pharmaceuticals, Inc.
CASI is a U.S. based biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients.CASI’s product pipeline features (1) EVOMELA®, MARQIBO®, and ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory process for market approval in China, (2) an acquired portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), one ANDA that was tentatively approved and three ANDAs that are pending FDA approval, from which CASI will prioritize a select subset for product registration and commercialization in China, (3) our proprietary drug candidate, ENMD-2076, currently in Phase 2 clinical development, and (4) proprietary early-stage candidates in immuno-oncology preclinical development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in the Company’s filings with the U.S. Securities and Exchange Commission.

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; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, the difficulty of executing our business strategy in China; the risk that we will not be able to effectively select, register and commercialize products from our recently acquired portfolio of ANDAs; our inability to predict when or if our product candidates will be approved for marketing by CFDA authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early- stage products under development; the risk that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). 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®, MARQIBO®, and ZEVALIN® are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates.

COMPANY CONTACT:
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com

INVESTOR CONTACT:
Torrey Hills Capital
Jim Macdonald
858.456.7300
jm@sdthc.com

Solebury Trout
Jennifer Porcelli
646.378.2962
jporcelli@troutgroup.com

Brennan Doyle
617.221.9005
BDoyle@troutgroup.com

CASI Pharmaceuticals To Present At The H.C. Wainwright Global Life Sciences Conference
ROCKVILLE, Md., April 3, 2018 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, announces it will present at the H.C. Wainwright Global Life Sciences Conference, April 8 – 10, 2018 in Monte Carlo, Monaco.

Presentation details are below:
Date: Tuesday, April 10, 2018
Time: 4:15 – 4:40 p.m. Local Time
Presenter: Ken K. Ren, Ph.D., Chief Executive Officer
Presentation Room: Salon Atlantic-W (2nd Floor), Le Meridien Beach Plaza Hotel, Monte Carlo

Event: H.C. Wainwright Global Life Sciences Conference

A copy of the presentation materials will be made available directly through the Investor Relations section of the company’s website, www.casipharmaceuticals.com, on April 10, 2018.

CASI Pharmaceuticals press release
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CASI Pharmaceuticals Announces Fourth Quarter And Full Year 2017 Financial Results
- Announced $50 million private placement to new and existing investors; previously completed $23.8 million registered direct offering
- Acquired portfolio of 25 US FDA-approved abbreviated new drug applications (ANDAs) from Sandoz Inc.

- EVOMELA® granted priority review by the China Food and Drug Administration (CFDA); MARQIBO® and ZEVALIN® review by CFDA in progress

ROCKVILLE, Md., March 29, 2018 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, today reported financial results for the fourth quarter and year ended December 31, 2017 and provided a review of recent accomplishments and anticipated upcoming milestones.

Wei-Wu He, Ph.D., Executive Chairman of CASI Pharmaceuticals, commented, “2017 was an exciting year for CASI and we have entered 2018 with the same strong momentum. We raised $50 million from new and existing investors, which leaves us well-positioned to launch EVOMELA® after the CFDA’s priority review is concluded.”

Dr. He continued, “We are incredibly excited by our recent acquisition of a portfolio of ANDAs from Sandoz. We saw an opportunity to acquire medicines already approved in the U.S. and delivering them to the large patient population in China seeking high quality medicines from abroad. We think this is an important new direction for the company and allows CASI the opportunity to commercialize a greater number of both high quality and innovative medicines to Chinese patients. We will prioritize the order in which we plan to introduce these medicines based on the commercial opportunity each present and intend to tap into our local networks and potential partners to accelerate commercialization and market penetration. The rapid change and improvement of the regulatory environment in Chinafor drug development coincides with our strategic mission in both the U.S. and China. Going forward, we plan to leverage our development, regulatory, and commercial infrastructure in China by continuing to add safe and effective medicines to our pipeline.”

Full Year and Recent Business Highlights
Financial Results for the Year ended December 31, 2017

Announced $50 million private placement to new and existing investors – In March 2018, the Company announced a $50 million private placement led by existing shareholders, ETP Global Fund LP and IDG-Accel China. Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc. participated as a new investor in CASI. The Company had previously closed on a $23.8 million registered direct offering in October 2017.
Acquired portfolio of 25 US FDA-approved ANDAs from Sandoz Inc. – In January 2018, the Company announced the acquisition of a portfolio of 25 US FDA-approved ANDAs, and one that the FDA tentatively approved and three that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that it believes have a unique market opportunity and can be manufactured cost-effectively in China and/or in the U.S.
EVOMELA® granted priority review by the CFDA; MARQIBO® and ZEVALIN® CFDA review in progress – In September 2017, the Company announced that the CFDA granted priority review for CASI’s import drug registration clinical trial application (CTA) for EVOMELA® (melphalan) for injection. The CFDA cited the following reasons as grounds for granting priority review (1) multiple myeloma is a rare disease, (2) there is no melphalan in any formulation available in China to address the unmet medical need, and (3) EVOMELA® has clear therapeutic advantages to currently available therapeutics. The CFDA review of CTAs for both MARQIBO® and ZEVALIN® is underway and progressing on schedule.
Cash Position: As of December 31, 2017, CASI had cash and cash equivalents of approximately $43.5 million.

R&D Expenses: Research and development (R&D) expenses for the year ended December 31, 2017 were $7.6 million compared to $4.6 million in 2016, an increase of $3.0 million. The increase in 2017 R&D spending primarily reflects $2.8 million in higher costs associated with the quality testing phase of the CFDA regulatory review of ZEVALIN® and EVOMELA® in 2017, as well as $0.2 million in additional personnel costs related to our preclinical activities in China.

G&A Expenses: General and administrative (G&A) expenses for the year ended December 31, 2017 were $3.2 million compared to $4.8 million in 2016. The increase of $1.6 million in G&A over the prior year primarily reflects an increase of $1.8 million in non-cash stock compensation offset by a $0.2 million increase in additional personnel costs related to business development activities.

Net Loss: The net loss for the year ended December 31, 2017 was ($10.8 million), or ($0.18) per share, compared with a net loss of ($9.5 million) or ($0.17) per share in 2016. The larger net loss in 2017 can be attributed to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN® and EVOMELA®, offset by less non-cash stock compensation expense during 2017.

Financial Results for the Quarter ended December 31, 2017

R&D Expenses: R&D expenses for the quarter ended December 31, 2017 were $3.8 million compared to $1.3 million in 2016, an increase of $2.5 million. The increase in R&D expenses primarily reflects continued investment in CASI’s development of approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. in China.

G&A Expenses: G&A expenses for the quarter ended December 31, 2017 were $1.2 million compared to $1.4 million in 2016. The decrease in G&A over the prior year primarily reflects the decrease in non-cash stock compensation expense offset by increases due to additional personnel within our business development function and higher professional fees. G&A expenses include non-cash share-based compensation of $0.1 million in the fourth quarter 2017 compared to $0.6 million in the fourth quarter 2016.

Net Loss: The Company reported a net loss of ($5.0 million), or ($0.08) per share, for the quarter ended December 31, 2017. This compares with a net loss of ($2.7 million), or ($0.05) per share for the fourth quarter of 2016. The increase in net loss is primarily due to costs associated with CFDA quality testing in support of CASI’s application for import drug registration of ZEVALIN®

CASI Pharmaceuticals Announces $50 Million Private Placement To Prepare Company For Commercialization In China
ROCKVILLE, Md., March 20, 2018 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, announces today a $50 million private placement. The Company has entered into definitive securities purchase agreements pursuant to which the Company will issue 15,432,091 shares of its Common Stock with accompanying warrants to purchase 6,172,832 shares of its Common Stock. The purchase price for each share of Common Stock and warrant is $3.24. The warrants will become exercisable 180 days after issuance at a $3.69 per share exercise price, and will expire five years from the date of issuance. On March 19, 2018, the consolidated closing bid price per share of Common Stock was $3.19.

The financing was led by ETP Global Fund LP, IDG-Accel China Growth Fund III, and Robert W. Duggan, former Chairman and CEO of Pharmacyclics Inc. The financing is expected to close on or about March 21, 2018. Proceeds will be used by the Company to prepare for the anticipated launch of its first commercial product in China and also for working capital general corporate purposes.

The offering of shares of Common Stock and warrants has not been registered under the Securities Act of 1933, as amended (the “Securities Act”) or any state securities laws, and the shares are being offered pursuant to an exemption from registration and in reliance on similar exemptions under applicable state laws. The investors will receive certain registration rights in connection with the offering.

Wei-Wu He, Ph.D., CASI’s Executive Chairman commented, “We are grateful that seasoned investors such as IDG and Mr. Duggan share our vision for CASI and our excitement as we prepare for the launch of our first commercial product in China. Our in-licensed products, EVOMELA®, MARQIBO® and ZEVALIN® are currently in various regulatory stages for market approval in China, with EVOMELA® under priority review. We also are working on our portfolio of 29 abbreviated new drug applications (ANDAs) (including 25 FDA-approved and 4 pending approval) that we recently acquired from Sandoz, and will continue to further expand our pipeline as part of our mission to bring innovative and high-quality medicines to the market.”

CASI Pharmaceuticals Announces Poster Presentation At The 2017 San Antonio Breast Cancer SymposiumTM (SABCS) On ENMD-2076 In Patients With Triple-Negative Breast Cancer (TNBC)
ROCKVILLE, Md., Dec. 1, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs announces a poster presentation on ENMD-2076 at the 2017 San Antonio Breast Cancer SymposiumTM (SABCS), December 5-9, 2017 in San Antonio, Texas.

ENMD-2076 is currently in a Phase 2 trial for the treatment of triple-negative breast cancer (TNBC) at two locations in the U.S. The poster will be presented in the session listed below and will be available on the CASI Pharmaceuticals website after the conclusion of the presentation.

Program Number: PD3-16
Abstract Number: 272
Session Title: Novel Drugs / Predicting Response for HER2+ Breast Cancer
Session Date: Thursday, December 7, 2017
Session Time: 7:00:00 AM – 9:00:00 AM CST
Title: "Clinical Safety and Efficacy of the Aurora and Angiogenic Kinase Inhibitor ENMD-2076 in Previously Treated, Locally Advanced or Metastatic Triple-Negative Breast Cancer"

CASI Pharmaceuticals Reports Third Quarter 2017 Financial Results

ROCKVILLE, Md., Nov. 14, 2017 - CASI Pharmaceuticals, Inc. (the “Company”) (CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, today reported financial results for the three and nine months ended September 30, 2017.

As of September 30, 2017, CASI had cash and cash equivalents of approximately $21.6 million.

CASI reported a net loss for the third quarter of 2017 of ($1.6 million), or ($0.03) per share. This compares with a net loss of ($1.7 million), or ($0.03) per share, for the same period last year. For the first nine months of 2017, the Company reported a net loss of ($5.7 million), or ($0.10)per share as compared to a net loss of ($6.8 million), or ($0.15) per share for the first nine months of 2016. The smaller net loss for the nine-month period in 2017 can be attributed to a decrease in non-cash compensation expense associated with the timing of stock option issuances and a decrease in clinical costs associated with the ENMD-2076 fibrolamellar trial, offset by an increase in R&D costs related to the advancement of EVOMELA®, MARQIBO®, and ZEVALIN® with the China Food and Drug Administration (CFDA) and an increase in costs related to our internal preclinical program.

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, “I am pleased with our third quarter financial results. In October, we announced a $23.8 million registered direct offering, funds raised from which will be used to advance our internal pipeline and support our business development in-license activities. With respect to existing in-licensed assets, we continue to advance EVOMELA®, MARQIBO®, and ZEVALIN® for the China market. EVOMELA® has been granted priority review by the CFDA, which we believe will accelerate its approval for the treatment of patients with multiple myeloma. We look forward to providing further updates on these in-licensed assets as well as on our internal pipeline candidates.”

May the Bands that you refer to, play sweet music!

I have been waiting since the 1990's. I'm now as hopeful and enthusiastic as ever. I am not an expert on stock trading, but I have never seen the volume (accumulation?) that I am seeing now before. I think I may remember one day of a million volume with Entremed but every single good day was always followed by many disappointing down days. Every seemingly good news story was always followed by drops in stock price--for over two decades! Still waiting for the news that will actually make this stock rise.

Rocky I

CASI Pharmaceuticals press release
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CASI PHARMACEUTICALS ANNOUNCES $23.8 MILLION REGISTERED DIRECT OFFERING LED BY EXISTING SHAREHOLDERS

ROCKVILLE, Md. (October 13, 2017) – CASI Pharmaceuticals, Inc. (the “Company”) (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced that it has entered into definitive agreements with certain institutional and accredited investors, including existing shareholders, to purchase approximately $23.8 million of securities in a registered direct offering. CASI expects to receive net proceeds of approximately $23.3 million after deducting agent’s fees and other offering expenses.

CASI has agreed to sell an aggregate of approximately 7,951,868 shares of its common stock and warrants to purchase shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.2 share of common stock will be sold for a purchase price of $3.00. The warrants will become exercisable six months after the issuance date and have a term of 2.5 years and an exercise price equal to $3.75. The offering is expected to close on or about October 17, 2017, subject to satisfaction of customary closing conditions.

Dr. Wei-Wu He, the Company’s Chairman, stated, ‘We are pleased with the return of our investors and the positive momentum of our Company. We intend to use the net proceeds to support our business development activities and drive the Company’s continued growth. We also are pleased with the China FDA’s recent public guidance that in its efforts to accelerate approvals for imported drugs, it plans to accept data from clinical trials outside of China. We believe this could potentially accelerate our pipeline of U.S. approved drugs that are currently under China FDA review, namely EVOMELA®, which has been granted priority review; and MARQIBO® and ZEVALIN®. We look forward to accelerating these medicines to the second largest pharmaceutical market, and will continue to add on to our pipeline.”

HC Wainwright acted as exclusive placement agent in this transaction. A shelf registration statement containing a prospectus relating to the shares of common stock and warrants to be issued in this transaction (and the shares of common stock issuable upon exercise of the warrants) has been filed with the Securities and Exchange Commission (the "SEC") and declared effective on October 15, 2015. A prospectus supplement relating to the offering will be filed by CASI with the SEC. Copies of the prospectus and prospectus supplement and accompanying prospectuses may be obtained directly from. This announcement is neither an offer to sell nor a solicitation of an offer to buy any securities of CASI. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

About CASI Pharmaceuticals, Inc.

CASI is a U.S. based, late-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China. CASI’s product pipeline features (1) EVOMELA®, MARQIBO® and ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory and clinical process for market approval in China, (2) CASI-001 and CASI-002, proprietary preclinical candidates in immune-oncology, and (3) our proprietary drug candidate, ENMD-2076, ongoing in one Phase 2 clinical study. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in CASI’s filings with the U.S. Securities and Exchange Commission.

CASI’s China rights to EVOMELA® (melphalan) for Injection, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and ZEVALIN® (ibritumomab tiuxetan) were previously licensed from its partner Spectrum Pharmaceuticals, Inc. Based on the U.S. FDA’s approval of these three licensed products, CASI is pursuing the Import Drug registration path for approval in China.

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: 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 volatility in the market price of our common stock; risks relating to interests of our largest stockholders that differ from our other stockholders; the risk of substantial dilution of existing stockholders in future stock issuances, the difficulty of executing our business strategy in China; our inability to predict when or if our product candidates will be approved for marketing by the China Food and Drug Administration authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with our product candidates; risks associated with any early-stage products under development; the risk that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; dependence on third parties; and risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks). 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®, MARQIBO® and ZEVALIN® are proprietary to Spectrum Pharmaceuticals, Inc. and its affiliates.

COMPANY CONTACT:
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com

INVESTOR CONTACT:
Torrey Hills Capital
Jim Macdonald
858.456.7300
jm@sdthc.com
Copyright © 2017 CASI Pharmaceuticals, Inc., All rights reserved.
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CASI Provides Pipeline Development Update
ROCKVILLE, Md., Sept. 7, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs today provided an update to its pipeline.

EVOMELA®:

China’s Food and Drug Administration (CFDA) has granted priority review for CASI’s import drug registration clinical trial application for EVOMELA (melphalan) for Injection. The CFDA cited the following three reasons for granting the priority review:

EVOMELA is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China;
There is no melphalan in any formulation available in China to address this unmet medical need;
EVOMELA has clear therapeutic advantages to currently available therapeutics.

MARQIBO® and ZEVALIN®:

The CFDA review of CASI’s MARQIBO import drug clinical trial application (CTA) is in process. The Company anticipates that the CFDA will complete its review of the CTA in the next four to six months, and expects to initiate the confirmatory trial within six months after CTA approval. The confirmatory trial is required as part of the registration process for the import drug registration.

The CFDA filing and review of CASI’s ZEVALIN import drug clinical trial application (CTA) is in process. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the clinical trial application require separate submissions to the CFDA, which the first part is currently under review and the latter part is in the submission process. The Company expects to initiate the confirmatory trial within six months after the CFDA’s approval of both the ZEVALIN kit and the Yttrium-90 submissions.

Ken Ren, Ph.D., CASI’s Chief Executive Officer, commented, “We are pleased that the CFDA in granting priority review for EVOMELA has recognized the superior therapeutic advantages of EVOMELA to address the urgent unmet medical need in the rare disease of multiple myeloma in China. Melphalan is extensively used worldwide in the treatment of patients with multiple myeloma, however, no formulation of melphalan is currently available in China. We appreciate the CFDA opening this accelerated pathway for this critical medicine to reach patients in China; it also is a positive signal from the CFDA to accelerate the import drug registration process for U.S. FDA approved drugs in order to address the significant unmet medical needs of the Chinese population in an accelerated time frame. We also are pleased with the progress of MARQIBO and ZEVALIN and are looking forward to their continued advancement in the import drug registration process.”

ENMD-2076:
Dr. Alex Zukiwski, M.D, CASI’s Chief Medical Officer, commented, “ENMD-2076 has been investigated in a number of tumor types based on the known mechanism of action and the oncogenic pathways of the specific malignancy. Although anticancer activity was observed in the clear cell ovarian carcinoma and soft tissue sarcoma studies, the level of single agent activity does not support the development of ENMD-2076 in these two tumor types as a monotherapy. We look forward to providing an update on the ENMD-2076 Triple Negative Breast Cancer and Fibrolamellar Carcinoma data in the next few months.”

Clear Cell Ovarian Carcinoma (CCOC) and Soft Tissue Sarcoma (STS). The data from the investigator-sponsored Phase 2 study in patients with CCOC was presented at the 2017 Annual Meeting of the American Society of Clinical Oncology. The data from the investigator-sponsored Phase 2 study in patients with STS was presented at the 2015 Annual Meeting of the Connective Tissue Oncology Society. The correlative genomics testing has been completed and a publication is expected to be submitted in 2017. Based on the clinical data, CASI has determined it will not pursue company sponsored development of ENMD-2076 in CCOC and STS.
Triple Negative Breast Cancer (TNBC). The accrual to the investigator sponsored Phase 2 study in patients with previously treated advanced and metastatic TNBC is complete and the correlative biomarker/genomics analysis is ongoing. The data will be presented at the 2017 San Antonio Breast Cancer Symposium.
Fibrolamellar Carcinoma (FLC). The accrual to this ongoing Phase 2 study is complete and is in the follow up phase. It is anticipated that the data from this study will be submitted to a medical conference for presentation in 2018.

CASI Pharmaceuticals To Present At The Annual Rodman & Renshaw Global Investment Conference
ROCKVILLE, Md., Sept. 6, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs announces it will present at the 19th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. The conference is being held on September 10-12, 2017 at Lotte New York Palace Hotel in New York City.

Event: 19th Annual Rodman & Renshaw Global Investment Conference
Date: Monday, September 11, 2017
Time: 3:25-3:50 PM (Eastern Time)
Presenter: Alexander A. Zukiwski, MD
Location: Holmes I; Lotte New York Palace Hotel in New York City

A copy of the presentation materials will be made available directly through the Investor Relations section of the company's website, www.casipharmaceuticals.com, on September 11, 2017.

About CASI Pharmaceuticals, Inc.

CASI is a U.S. based, late-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a focus on commercialization in China. CASI's product pipeline features (1) EVOMELA®, MARQIBO® and ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for Chinaregional rights, and currently in various stages of the regulatory process for market approval in China, (2) proprietary drug candidate, ENMD-2076, ongoing in one Phase 2 clinical study, and (3) CASI-001 and CASI-002, proprietary preclinical candidates in immuno-oncology. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in CASI's filings with the U.S. Securities and Exchange Commission.

ROCKVILLE, Md., May 30, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs announces a poster presentation on ENMD-2076 at the American Society of Clinical Oncology Annual Meeting being held June 2 – 6, 2017 in Chicago. ENMD-2076 is currently in a Phase 2 trial for the treatment of clear cell ovarian carcinoma (CCOC) at Princess Margaret Hospital Centre in Toronto. The poster will be presented in the sessions listed below and will be available on the CASI Pharmaceuticals website afterward.

Gynecologic Cancer:
General Poster Session
Saturday, June 3, 2017, 1:15PM – 4:45PM (CDT)
Abstract No.: 5522, Poster Board No.: 344
Title: Phase II clinical and molecular trial of oral ENMD-2076 in clear cell ovarian cancer (CCOC): A study of the Princess Margaret Phase 2 consortium
Location: Hall A
Poster Discussion Session
Saturday, June 3, 2017, 4:45PM – 6:00PM (CDT)
Location: Arie Crown Theater

CASI Pharmaceuticals Announces Abstract On ENMD-2076 In Clear Cell Ovarian Cancer
Poster to be Presented at 2017 ASCO Annual Meeting
ROCKVILLE, Md., May 18, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs today reported the availability of an abstract titled "Phase II Clinical and Molecular Trial of Oral ENMD-2076 in Clear Cell Ovarian Cancer (CCOC)" that was published on May 17, 2017 and is the subject of a poster to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 2-6, 2017 in Chicago, Illinois. The abstract is available at: http://abstracts.asco.org.

Alex Zukiwski, M.D., CASI's Chief Medical Officer, commented, "The abstract analyzes the data from an investigator-initiated study of ENMD-2076 in pretreated patients with recurrent CCOC conducted by the Princess Margaret Phase 2 Consortium. The trial completed enrollment of 40 patients (37 evaluable) with biomarker analysis still ongoing. The primary endpoints of the study were progression free survival rate (PFS) at 6 months and objective response rate. Exploratory objectives incorporated evaluation of correlative biomarkers on patient outcomes, including the evaluation of ARID1A status which is a known negative prognostic factor in CCOC. The estimated six-month PFS rate was 20% for the evaluable patients, 31% for patients with ARID1A loss, and 12% for patients with ARID1A positive. Median PFS was 3.7 months (m) (95%CI: 3.4-4.4m), in ARID1A loss (19 pts) was 4.1m (95%CI: 3.5-10.3m) vs 3.6m (95%CI: 1.7-3.9m) in ARID1A positive (17 pts) (p=0.024). The loss of ARID1A on archival tissue seems to be associated with better PFS on ENMD-2076. Two patients achieved a partial response (1 unconfirmed) as per RECIST v1.1 criteria."

Dr. Zukiwski continued, "CCOC is a rare type of ovarian cancer which is difficult to treat and is shown to be relatively non responsive to standard chemotherapy agents. The identification of what appears to be an improved PFS in the patient group with ARID1A loss is encouraging and needs to be further assessed as this potential biomarker could allow for selection of patients who may potentially benefit from ENMD-2076. Evaluation of the clinical data and the correlative biomarker program continues and will help determine the development path in CCOC and potentially for the other tumor types for which ARID1A loss or mutation has been identified."

CASI Pharmaceuticals Reports First Quarter 2017 Financial Results
ROCKVILLE, Md., May 15, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs today reported financial results for the three months ended March 31, 2017.

CASI reported a net loss for the first quarter of 2017 of ($1.7 million), or ($0.03) per share, compared with a net loss of ($1.8 million), or ($0.04) per share, for the same period last year. The smaller net loss stems from a decrease in non-cash compensation expense associated with the timing of stock option issuances, offset by an increase in costs related to the expansion of our China operations.

As of March 31, 2017, CASI had cash and cash equivalents of $25.5 million.

Dr. Ken Ren, Chief Executive Officer, commented, “Our first quarter financial results were as expected and reflect the operational efficiencies we continue to achieve. We continue to make progress with our programs, while also pursuing business development opportunities to expand our pipeline, and remain committed to becoming a fully-integrated multi-national pharmaceutical company.”

CASI Pharmaceuticals Reports On Enrollment Status Of ENMD-2076 Phase 2 Study In Triple-Negative Breast Cancer
ROCKVILLE, Md., April 14, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported today that along with the investigators a decision has been reached to stop further patient enrollment in its Phase 2, open-label study of ENMD-2076 in previously treated locally advanced or metastatic triple-negative breast cancer (TNBC) conducted at the University of Colorado, Denver and the Indiana University Melvin and Bren Simon Cancer Center. The study was a 2 stage design which targeted an accrual of 35 patients. The patient number was expanded to take into consideration those patients which may not be evaluable for efficacy analysis as per the protocol. In this uncommon tumor type and challenging setting to recruit, a total of 41 patients have been enrolled which has been determined to be sufficient to assess the potential efficacy of ENMD-2076 in this patient population and for our ongoing biomarker analysis. The Company continues to collect and evaluate data in those patients enrolled in the study, and the biomarker program which evaluates potential markers that could be predictive of a response to ENMD-2076 is ongoing. In addition, the ongoing Phase 2a study in China in patients with TNBC continues to accrue patients in the dose escalation phase, the primary objective of which is to determine the recommended Phase 2 dose in Chinese study subjects. This dose escalation phase is expected to reach the full accrual target in Q3 2017.

Dr. Alex Zukiwski, CASI's Chief Medical Officer, commented, "We continue to evaluate the maturing data including the biomarker analysis to determine the potential future development path in patients with TNBC. Identifying markers predictive of response to ENMD-2076 in patients with TNBC would be helpful to future development as a single agent, as well as consideration of any additional trials where ENMD-2076 could be combined with approved agents to increase clinical benefit."

Along with the investigators, the Company plans to present the study results at the next available opportunity.

CASI Pharmaceuticals Reports 2016 Fourth Quarter And Full Year Financial Results

ROCKVILLE, Md., March 31, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, today reported financial results for the three and 12 months ended December 31, 2016.

The Company reported a net loss of ($2.7 million), or ($0.05) per share, for the three months ended December 31, 2016. This compares with a net loss of ($1.7 million), or ($0.05) per share for the fourth quarter of 2015. The increase in net loss is due to non-cash stock compensation expense of $0.7 million related to stock option issuances associated with financings completed in the fourth quarter of 2016, as well as increased costs associated with the expansion of our China operations.

The net loss for the year ended December 31, 2016 was ($9.5 million), or ($0.17) per share, compared with a net loss of ($7.2 million) or ($0.22) per share for 2015. The larger net loss for 2016 can be attributed to (i) an increase in non-cash stock compensation expense of $2.1 million related to stock option issuances associated with completed financings and (ii) increased costs associated with our Phase 2 Trial for ENMD-2076 in fibrolamellar carcinoma.

As of December 31, 2016, CASI had cash and cash equivalents of $27.1 million.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2016, can be found at www.casipharmaceuticals.com.

Ken K. Ren, Ph.D., Chief Executive Officer, commented, "Our financial results for the fourth quarter and year ended December 31, 2016 were as expected. Our import drug registration activities in China for MARQIBO®, EVOMELA®, and ZEVALIN® are ongoing as we continue the process towards approval. We continue the clinical evaluation of our lead proprietary drug candidate, ENMD-2076, and at the same time, further our business development activities to expand our pipeline. We are carefully managing our expenses, and are looking forward to achieving interim milestones and building value for our shareholders."

CASI Pharmaceuticals Reports 2016 Fourth Quarter And Full Year Financial Results

ROCKVILLE, Md., March 31, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, today reported financial results for the three and 12 months ended December 31, 2016.

The Company reported a net loss of ($2.7 million), or ($0.05) per share, for the three months ended December 31, 2016. This compares with a net loss of ($1.7 million), or ($0.05) per share for the fourth quarter of 2015. The increase in net loss is due to non-cash stock compensation expense of $0.7 million related to stock option issuances associated with financings completed in the fourth quarter of 2016, as well as increased costs associated with the expansion of our China operations.

The net loss for the year ended December 31, 2016 was ($9.5 million), or ($0.17) per share, compared with a net loss of ($7.2 million) or ($0.22) per share for 2015. The larger net loss for 2016 can be attributed to (i) an increase in non-cash stock compensation expense of $2.1 million related to stock option issuances associated with completed financings and (ii) increased costs associated with our Phase 2 Trial for ENMD-2076 in fibrolamellar carcinoma.

As of December 31, 2016, CASI had cash and cash equivalents of $27.1 million.

Further information regarding the Company, including its Annual Report on Form 10-K for the year ended December 31, 2016, can be found at www.casipharmaceuticals.com.

Ken K. Ren, Ph.D., Chief Executive Officer, commented, "Our financial results for the fourth quarter and year ended December 31, 2016 were as expected. Our import drug registration activities in China for MARQIBO®, EVOMELA®, and ZEVALIN® are ongoing as we continue the process towards approval. We continue the clinical evaluation of our lead proprietary drug candidate, ENMD-2076, and at the same time, further our business development activities to expand our pipeline. We are carefully managing our expenses, and are looking forward to achieving interim milestones and building value for our shareholders."

CASI Pharmaceuticals Announces Poster Presentations At AACR Annual Meeting
ROCKVILLE, Md., March 28, 2017 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today two poster presentations at the American Association for Cancer Research annual meeting. The first poster to be presented on April 3 is entitled “Evaluation of ENMD-2076 in Combination with Anti-PD1 in Syngeneic Cancer Models” and the second poster to be presented on April 4 is entitled “Kinase Inhibitor Demonstrates Efficacy in Patient Derived Xenograft Model of Fibrolamellar Hepatocellular Carcinoma Featuring DNAJB1-PRKACA Gene Fusion.”

Session Category: Immunology
Session Title: Tumor Microenvironment and Checkpoints
Session Date and Time: Monday Apr 3, 2017, 8:00 AM - 12:00 PM ET
Location: Convention Center, Halls A-C, Poster Section 27
Poster Board Number: 20
Permanent Abstract Number: 1642

Session Category: Experimental and Molecular Therapeutics
Session Title: Targeting Protein Kinases and DNA Repair
Session Date and Time: Tuesday Apr 4, 2017 1:00 PM - 5:00 PM ET
Location: Convention Center, Halls A-C, Poster Section 7
Poster Board Number: 26
Permanent Abstract Number: 4203

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CASI Pharmaceuticals’ Import Drug Registration Application For EVOMELA® Accepted For Review By CFDA
ROCKVILLE, Md., Dec. 5, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today that China’s Food and Drug Administration (CFDA) has accepted for review the Company’s import drug registration application for EVOMELA® (melphalan) for Injection.

CASI’s China rights to EVOMELA (melphalan) for Injection was previously licensed from its partner Spectrum Pharmaceuticals, Inc. along with two other commercial-stage Spectrum drugs, MARQIBO® and ZEVALIN®. EVOMELA received U.S. FDA approval earlier this year for multiple myeloma patients as a high-dose conditioning treatment prior to autologous stem cell transplantation (ASCT) and as palliative treatment for patients who are not candidates for oral therapy. It was launched in the U.S. this year by Spectrum.

Ken Ren, Ph.D, CASI’s Chief Executive Officer, commented, “Multiple myeloma is the second most common malignancy in blood cancers, often occurring in elderly patients. There were more than 12,000 new cases and more than 9,000 deaths from multiple myeloma in China in 2015. With the aging of China’s population, the number of new cases is rapidly rising. Melphalan is extensively used worldwide in the treatment of multiple myeloma and is the main drug in pre-transplant conditioning therapy. Melphalan, however, is not currently commercially available in China. EVOMELA, an innovative and proprietary new formulation of melphalan, offers significant advantage in that it (i) does not contain propylene glycol which causes significant side effects; (ii) has longer stability; and (iii) is the only intravenous melphalan product approved for use in the high-dose conditioning indication. We look forward to working with the CFDA to advance EVOMELA towards market approval.”

CASI Pharmaceuticals Provides Update On Phase 2 Trial Of ENMD-2076 In Fibrolamellar Carcinoma

ROCKVILLE, Md., Aug. 16, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, today announced that its Phase 2 trial of ENMD-2076 in fibrolamellar carcinoma (FLC) has met its Stage 1 endpoint of objective response for non-futility based on the pre-specified interim analysis criteria and will advance to Stage 2 development.

Rong Chen, M.D., CASI’s Chief Medical Officer, commented, “The trial is to evaluate safety and efficacy of ENMD-2076 as a single agent in a total of 29 locally-advanced or metastatic FLC patients. It uses a Simon’s optimal two-stage design to allow for an early determination of potential futility in the 16 patients of Stage 1. An additional 13 patients will be recruited in Stage 2 to allow an overall final analysis with sufficient power. Having met the Stage 1 endpoint, we will now advance the trial to Stage 2 development. Meanwhile, the Stage 1 remains ongoing with approximately one-third of the patients still under treatment. A full interim analysis will be conducted and reported after all 16 patients have reached study endpoint of responses.”

Ken Ren, Ph.D., CASI’s Chief Executive Officer, commented, “We are pleased to see our FLC trial advance into Stage 2, which upon completion will increase the amount of data of ENMD-2076 in FLC patients. FLC is a life-threatening disease that typically affects young adults and is currently without any systemic treatment. Based on results to date, we are encouraged by the potential of ENMD-2076 to address the unmet medical needs of these patients. We are thankful to our investigators for their dedication to the program and to our FLC patients who make the trial meaningful and drive our purpose.”

More information about the trial can be found at www.clinicaltrials.gov.

CASI: Company Announces Positive Phase II Data on ENMD-2076 in Patients with OCCC At ASCO
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CASI: Company Announces Positive Phase II Data on ENMD-2076 in Patients with OCCC At ASCO

By Grant Zeng

NASDAQ:CASI

The Poster Presentation

During the 2016 ASCO meeting held June 3-7 at Chicago, CASI made a poster presentation about its lead candidate ENMD-2076 for ovarian clear cell carcinoma (OCCC).

OCCC represents 6% of all epithelial ovarian carcinomas and is associated with chemotherapy resistance and worse prognosis with advanced disease. Approximately 50% of OCCC are characterized by inactivating mutations in ARID1A and upregulation of PIK3/AKT/mTOR pathway. ENMD-2076, is an oral anti-angiogenic/anti-proliferative kinase inhibitor against the mitotic kinase Aurora A.

The poster title is: Antitumor Activity, Safety and Predictive Biomarker Results of ENMD-2076 Administered to Patients (pts) with Recurrent Ovarian Clear Cell Carcinoma (OCCC): A Trail of the Princess Margaret Phase II Consortium.

This is a multi-center, open-label, Phase II study of single agent ENMD-2706 (275 mg daily, 28 day
Cycle) in patients with recurrent OCCC.

The primary objectives include
• assessment of the anticancer activity of ENMD-2076 defined by the 6- month PFS rate,
• assessment of the objective response rate (ORR) using RECIST 1.1 criteria.
Secondary objectives include
• determination of duration of response
Exploratory objectives include
• correlation between somatic mutations in PI3KCA, ARID1A and PTEN and patient outcome.
• correlation between expression of ARID1A and PTEN by immunohistochemistry in archival samples and pretreatment tumor biopsies with patient outcome.

Data from 37 patients were presented. ENMD-2076 was generally well tolerated with a side effect profile typical of this class of agent.

6-month PFS rate was 0.16. 6-month PFS rate for ARID1A negative was 28% vs 0% for ARID1A positive. Overall response rate was 11%.


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The correlation of PIK3CA status and PFS was significant. In wild type PIK3CA patients, median PFS was 5.7 months vs 3.7 months in PIK3CA mutant patients (p=0.07).

The correlation between ARID1A-IHC status and PFS was also significant. In ARID1A-IHC negative patients, median PFS was 4.1 months vs 3.7 months for ARID-IHC positive patients (p=0.026).
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Our Takeaways from the data presentation

These data showed that ENMD-2076 demonstrated antitumor activity in OCCC and was generally well tolerated. We are especially interested in the correlation between PIK3CA/ARID1A status and ENMD-2076 antitumor activity. The significant relationships between wild type PIK3CA and PFS and between negative ARID1A and PFS are worth further investigation and may become a criteria for choosing OCCC patients in new clinical trials

CASI Pharmaceuticals Announces Poster Presentation At ASCO On ENMD-2076 In Patients With Ovarian Clear Cell Carcinoma (OCCC)
Antitumor Activity, Safety and Predictive Biomarker Results to be Presented
ROCKVILLE, Md., June 1, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces a poster presentation on ENMD-2076 at the American Society of Clinical Oncology Annual Meeting. ENMD-2076 is currently in a Phase 2 trial for the treatment of ovarian clear cell carcinoma (OCCC) at Princess Margaret Hospital Centre in Toronto. ASCO will be held June 3 – 7, 2016 in Chicago. The poster will be presented in the session listed below and will be available on the CASI Pharmaceuticals website afterward.

Gynecologic Cancer:
General Poster Session
Monday, June 6, 2016, 1:00PM – 4:30PM (CDT)
Abstract No.: 5564, Poster Board No.: 387
Title: Antitumor Activity, Safety and Predictive Biomarker Results of ENMD-2076 Administered to Patients (pts) with Recurrent Ovarian Clear Cell Carcinoma (OCCC): A Trail of the Princess Margaret Phase II Consortium
Location: Hall A

CASI Pharmaceuticals Announces Poster Presentation At ASCO On ENMD-2076 In Patients With Ovarian Clear Cell Carcinoma (OCCC)
Antitumor Activity, Safety and Predictive Biomarker Results to be Presented
ROCKVILLE, Md., June 1, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces a poster presentation on ENMD-2076 at the American Society of Clinical Oncology Annual Meeting. ENMD-2076 is currently in a Phase 2 trial for the treatment of ovarian clear cell carcinoma (OCCC) at Princess Margaret Hospital Centre in Toronto. ASCO will be held June 3 – 7, 2016 in Chicago. The poster will be presented in the session listed below and will be available on the CASI Pharmaceuticals website afterward.

Gynecologic Cancer:
General Poster Session
Monday, June 6, 2016, 1:00PM – 4:30PM (CDT)
Abstract No.: 5564, Poster Board No.: 387
Title: Antitumor Activity, Safety and Predictive Biomarker Results of ENMD-2076 Administered to Patients (pts) with Recurrent Ovarian Clear Cell Carcinoma (OCCC): A Trail of the Princess Margaret Phase II Consortium
Location: Hall A

CASI Pharmaceuticals Reports First Quarter 2016 Financial Results

ROCKVILLE, Md., May 13, 2016 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs today reported financial results for the three months ended March 31, 2016.

The Company reported a net loss for the first quarter of 2016 of ($1.8 million), or ($0.04) per share, compared with a net loss of ($1.8 million), or ($0.06) per share, for the same period last year. As of March 31, 2016, CASI had cash and cash equivalents of $13.9 million.

Sara B. Capitelli, Vice President, Finance and Principal Accounting Officer, commented, “Our research and development expenses for the first quarter increased over the prior year due to start-up costs and patient enrollment costs associated with our FLC trial in the U.S. Our general and administrative expenses for the first quarter decreased over the prior year due to cost savings associated with business development and investor relations activities. As we continue to execute our clinical development plans in the U.S., Canada and China, we expect operating expenses to increase in 2016.”

Dr. Ken Ren, Chief Executive Officer, commented, “We are pleased with our first quarter financial results, which are indicative of the operational efficiencies we have achieved. Our fundamentals remain strong and we believe the outlook for CASI is excellent. In 2016, we look forward to further advancement of ENMD-2076 and our other internal programs, and further progress in our in-licensed programs from Spectrum Pharmaceuticals. With the recent expansion of our business development team, we expect to accelerate our licensing activities and secure further partnerships to expand our pipeline as we move forward to becoming a fully-integrated world-class pharmaceutical company.”