Supernus to Present at Two September Healthcare Conferences

On August 26, 2019 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present a Company overview and update, as well as host investor meetings, at the following September conferences (Press release, Supernus, AUG 26, 2019, View Source [SID1234538997]):

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Wells Fargo 2019 Healthcare Conference
Date: Thursday, September 5, 2019
Time: 1:20 p.m. ET
Place: The Westin Copley Place, Boston, MA

Morgan Stanley 2019 Global Healthcare Conference
Date: Wednesday, September 11, 2019
Time: 11:05 a.m. ET
Place: Grand Hyatt New York in New York City
Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinator.

A live webcast of the presentations can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days on the Company’s website after the conference.

Gilead Sciences to Present at the Morgan Stanley Global Healthcare Conference on Tuesday, September 10

On August 26, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that Daniel O’Day, Gilead’s Chairman and Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference in New York on Tuesday, September 10 at 10:00 a.m. Eastern Time (Press release, Gilead Sciences, AUG 26, 2019, View Source [SID1234539018]).

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The audio portion of the fireside chat will be accessible live through the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation.

CStone announces first patient dosed in China for Phase I/II registrational bridging trial of avapritinib in advanced GIST

On August 25, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that the first patient in China has been dosed in the Phase I/II bridging study of avapritinib, which was discovered by CStone’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, AUG 25, 2019, View Source [SID1234538983]). This stand-alone registrational bridging study in China includes a Phase I dose-escalation study and Phase II dose-expansion study, with the aim of evaluating the safety, pharmacokinetics and efficacy of avapritinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). This study consists of patients with PDGFRA D842V-driven GIST, as well as second- and third-line or later GIST patients.

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GIST is a sarcoma most commonly found in the stomach wall or small intestine. Most GIST patients are diagnosed between the ages of 50 to 80. Approximately 90% of GIST cases are associated with dysregulation of cell growth due to mutations of KIT and PDGFRA tyrosine kinases. Currently, there are no effective therapies for patients with PDGFRA D842V-driven GIST.

Avapritinib is an orally available, potent and highly selective inhibitor of KIT and PDGFRA. Previously published preclinical results have shown that avapritinib has potent activity against KIT and PDGFRA mutant kinases associated with GIST.

In June 2018, CStone entered into an exclusive collaboration and license agreement with Blueprint Medicines to develop and commercialize three therapeutic candidates, including avapritinib, in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for the three therapeutic candidates in the rest of the world.

Dr. Frank Jiang, Chairman and CEO of CStone, commented: "GIST is a rare disease with rising incidence rates in recent years, and PDGFRA D842V-mutant GIST patients still lack effective treatments. CStone is committed to the development of innovative therapies to meet urgent clinical needs. Our partner Blueprint Medicines has submitted an NDA for avapritinib in the U.S. and a marketing authorization application in the European Union. We are following their footsteps in seeking to make this novel precision therapy accessible to patients in Greater China as soon as possible. "

CStone’s Chief Medical Officer Dr. Jason Yang noted: "Early symptoms of GIST are relatively unpronounced; as a result, some GIST patients are undiagnosed until advanced stages. Data presented at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting demonstrated an objective response rate (ORR) of 86% and favorable tolerability in patients with PDGFRA Exon 18 mutant GIST in the global Phase I NAVIGATOR study of avapritinib. We have already initiated two registrational studies on avapritinib in China, both of which have enrolled their first patients. We will do our best to accelerate the development of this drug candidate and successfully bring it to the market in Greater China."

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The U.S. FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Data presented at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting from the global Phase I NAVIGATOR study of avapritinib are based on a data cutoff date of November 16, 2018.

Concord Medical Reports Financial Results for the First Half of 2019

On August 23, 2019 Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a specialty hospital management group and an operator of the network of radiotherapy and diagnostic imaging centers in China, reported its unaudited consolidated financial results for the six months ended June 30, 2019[1] (Press release, Concord Medical Services Holdings, AUG 23, 2019, View Source [SID1234538964]).

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2019 First Half Highlights

Total net revenues were RMB99.5 million ($14.5 million) in the first half of 2019, a 5.3% decrease from total net revenues of RMB105.1 million in the same period last year. Total net revenues included net revenue from the network business of RMB68.0 million ($9.9 million) and net revenue from hospital business of RMB31.5 million ($4.6 million).
Gross profit was RMB3.1 million ($0.5 million) in the first half of 2019, representing an 87.0% decrease from RMB23.9 million in the first half of 2018. The gross profit margin was 3.1% for the first half of 2019, compared to 22.8% for the same period last year.
Net loss attributable to ordinary shareholders in the first half of 2019 was RMB140.1 million ($20.4 million), compared to RMB128.1 million in the same period last year.
Basic and diluted loss per American Depositary Share ("ADS")[2] in the first half of 2019 were both RMB6.10 ($0.89), compared to RMB2.95, respectively, in the same period last year.
Non-GAAP net loss in the first half of 2019 was RMB149.3 million ($21.7 million), compared to non-GAAP net loss of RMB121.5 million in the same period last year. Non-GAAP basic and diluted loss per ADS in the first half of 2019 were both RMB3.44 ($0.50), compared to RMB2.81 in the same period last year.
Adjusted EBITDA[3] (non-GAAP) was negative RMB108.3 million ($15.8 million) in the first half of 2019, compared to negative RMB73.3 million in the same period last year.
Dr. Jianyu Yang, Chairman and Chief Executive Officer of Concord Medical, commented, "With the smooth construction of the Company’s hospitals, the corresponding costs have increased and have had an impact on the Company’s financial results. However, the year 2018-2019 was an important stage for the Company’s business development. In 2018, the Company received financing from strategic investors. In 2019, the Company’s three premium cancer hospitals are all under construction. Beijing Proton Medical Center and Guangzhou Concord Cancer Center are expected to commence the operations in 2020. The Company believes that its performance will be greatly improved."

"The proportion of revenue generated from the hospital business is increasing gradually. Revenue from the Company’s hospital business accounted for 32% of total revenue during the first half of 2019, representing an 8% increase from 24% in the first half of 2018. During the first half of 2019, Shanghai Meizhong Jiahe Cancer Center (also known as Shanghai Concord Medical Cancer Center) handled 4,758 patient treatment cases and patient diagnostic cases, representing a 190% increase from the same period last year."

"In the future, the Company will utilize its strengths in cancer treatment and explore business opportunities in the operation and management of cancer franchise hospitals and proton center operations."

2019 First Half Financial Results

Network Business

Net revenues from the network business were RMB68.0 million ($9.9 million), representing a 14.4% decrease from net revenues of RMB79.4 million in the first half of 2018, primarily attributable to the closure of certain centers in our network of centers. With one center closed in the first half of 2019, the Company operated a network of 30 centers in 20 cities in China as of June 30, 2019.

Cost of revenue of the network business was RMB34.8 million ($5.1 million), representing a 18.9% decrease from RMB42.9 million in the first half of 2018.

Gross profit from the network business was RMB33.2 million ($4.8 million), representing a 9.0% decrease from RMB36.5 million in the first half of 2018. The gross profit margin for the first half of 2019 was 48.8%, compared to 46.0% for the same period last year.

Selling expenses of the network business were RMB9.3 million ($1.4 million), representing a 6.1% decrease from RMB9.9 million in the first half of 2018. Selling expenses as a percentage of net revenues was 13.7% in the first half of 2019, compared to 12.5% in the first half of 2018. The decrease in selling expenses of the network business was mainly due to reduced marketing, conference, office and travel expenses.

General and administrative expenses of the network business were RMB82.5 million ($12.1 million), representing a 0.3% increase from RMB82.6 million in the first half of 2018. General and administrative expenses as a percentage of net revenues were 121.9% in the first half of 2019, compared to 104.0% in the same period last year. The increases were mainly due to the counsel fee and travel expense related to the closure of certain centers.

Comparing to RMB4.8 million in the same period last year, capital expenditures increased to RMB24.8 million ($3.6 million) in the first half of 2019 primarily for procuring equipment for network centers.

Accounts receivable were RMB85.0 million ($12.4 million) as of June 30, 2019, compared to RMB82.0 million as of December 31, 2018. The average period of sales outstanding for accounts receivable (also known as "Days Sales Outstanding") was 221 days in the first half of 2019.

During the first half of 2019, the Company handled 5,334 patient treatment cases and 74,721 patient diagnostic cases, representing a 0.4% decrease and a 5.9% increase from the same period last year, respectively. The increase in patient diagnostic cases was mainly due to the counting of the cases from a center which entered into network contract with the Company in December 2018.

Hospital Business

Net revenues from the hospital business were RMB31.5 million ($4.6 million) in the first half of 2019, representing a 22.6% increase from net revenues of RMB25.7 million in the first half of 2018, mainly due to the consolidation of Shanghai Meizhong Jiahe Cancer Center Co., Ltd. in the fourth quarter of 2018.

Cost of service of the hospital business in the first half of 2019 was RMB61.6 million ($9.0 million), a 60.8% increase from cost of service of RMB38.3 million in the first half of 2018, mainly because of the consolidation of Shanghai Meizhong Jiahe Cancer Center Co., Ltd. in the fourth quarter of 2018.

Gross loss from the hospital business was RMB30.1 million ($4.4 million) in the first half of 2019, compared to RMB12.6 million in same period last year.

Selling expenses of the hospital business were RMB1.5 million ($0.2 million) in the first half of 2019, representing a 114.3% increase from selling expenses of RMB0.7 million in the first half of 2018. The increase was mainly due to the consolidation of Shanghai Meizhong Jiahe Cancer Center Co., Ltd. in the fourth quarter of 2018.

General and administrative expenses of the hospital business were RMB57.0 million ($8.3 million) in the first half of 2019, of which employee benefit expenses were RMB19.9 million ($2.9 million). In the same period of last year, general and administrative expenses of the hospital business were RMB31.8 million. The increase was mainly due to the increase in salary and consultation fees for hospitals.

Comparing to RMB282.1 million in the first half of 2018, capital expenditures of the hospital were RMB410.5 million ($59.8 million) in the first half of 2019, which was mainly related to the construction fees and medical equipment payment for Beijing Proton Medical Center, Shanghai Concord Cancer Center and Guangzhou Concord Cancer Center.

As of June 30, 2019, accounts receivable from hospital business were RMB10.9 million ($1.6 million), a 55.7% increase from accounts receivable of RMB7.0 million as of December 31, 2018. The number of Days Sales Outstanding was 51 days in the first half of 2019.

As of June 30, 2019, the Company had bank loan totaling RMB1.1 billion ($163.0 million).

Recent Developments

Starting from February 20, 2019, the basic medical services of Shanghai Meizhong Jiahe Cancer Center (also known as Shanghai Concord Medical Cancer Center) used by Shanghai medical insurance participants have been fully covered by medical insurance. Moreover, effective on July 22, 2019, Shanghai Meizhong Jiahe Cancer Center has become a designated hospital in Shanghai, allowing the general outpatient services and the major outpatient services (including radiotherapy and chemotherapy for malignant tumors) to be settled by medical insurance according to the standard of the local third-level hospitals.

Shanghai Meizhong Jiahe Medical Imaging Diagnostic Center (also known as Shanghai Concord Medical Imaging Diagnostic Center) has completed the construction stage and is expected to commence a trail operation in the third quarter of 2019.

Notes:

[1] This announcement contains translations of certain RMB amounts into U.S. dollars at specified rates solely for the convenience of the reader. Unless otherwise noted, all translations of RMB into U.S. dollars are made at a rate of RMB6.8650 to $1.00, the noon buying rate in New York City for cable transfers payable in RMB, as certified for customs purposes by the Federal Reserve Bank of New York on June 30, 2019.
[2] Each ADS represents three Class A ordinary shares of the Company; the Company adjusts for the accretion of mezzanine equity in the calculation of loss attributable to ordinary shareholders of the Company used in the earnings per ADS calculation.
[3] Adjusted EBITDA is defined as net income plus interest, taxes, depreciation and amortization, share-based compensation expenses, and other adjustments. Other adjustments include foreign exchange gain, loss on disposal of long-lived assets and other income.

[PDF]Cantargia and BioWa extend ongoing collaboration around the POTELLIGENT® Technology

On August 23, 2019 Cantargia AB and BioWa Inc. reported that it have signed an extension of the license agreement around the BioWa proprietary POTELLIGENT Technology for production of Cantargia’s antibody drug candidate CAN04, which gives Cantargia broader rights to use the technology (Press release, Kyowa Hakko Kirin, AUG 23, 2019, View Source [SID1234539061]). Since the original agreement allowing use of POTELLIGENT Technology was signed in 2015, Cantargia has advanced CAN04 to phase IIa clinical development for potential use in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC).

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Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The POTELLIGENT technology generates antibodies with enhanced antibody dependent cellular cytotoxicity (ADCC). The investigational antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signaling. CAN04 is currently produced in a Chinese Hamster Ovary (CHO) cell line provided by BioWa which has been engineered using POTELLIGENT Technology. The extended agreement enables Cantargia to create and use additional CHO cell lines engineered using POTELLIGENT Technology and develop and commercialize CAN04 made through such CHO cell line.

With CAN04 having reached phase IIa clinical development, the next step in the production development is to further reduce production costs using various process improvements as well as scaling up, and Cantargia and BioWa have agreed to extend the current license to include additional opportunities.

"We are extremely pleased with our collaboration with BioWa and the amended agreement is a logical step in our long-term relationship. Given the successful advances of CAN04, optimization of the production process to reduce cost is part of the CAN04 development plan", Göran Forsberg, Cantargia’s CEO says.

"We believe that this extension of the license agreement would add benefits into the fruitful collaboration between Cantargia and BioWa." said Takeshi Masuda, BioWa’s President and CEO. "We are very pleased that this amended agreement could support the innovative program going forward".

For further information, please contact
Cantargia:
Göran Forsberg
CEO
Telephone: +46(0)46-275-62-60
E-mail: [email protected]

BioWa:
Shintaro Hasegawa
Director, Business Development
Telephone: +1-609-580-7340
E-mail: [email protected]

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on August 23, 2019.