Rocky I
5年前
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.
Rocky I
5年前
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.
Rocky I
6年前
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.
Rocky I
6年前
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.
Rocky I
6年前
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."
Rocky I
6年前
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.
Rocky I
6年前
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."
Rocky I
6年前
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
Rocky I
6年前
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).”
Rocky I
6年前
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.
Rocky I
7年前
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
Rocky I
7年前
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
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