Cantargia and BioWa Extend Ongoing Collaboration around the POTELLIGENT® Technology

On August 23, 2019 Cantargia AB and BioWa Inc. reported that they 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, Cantargia, AUG 23, 2019, View Source [SID1234538962]). 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".

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.

Tmunity Announces Participation at Upcoming Investor Conferences

On August 23, 2019 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported that Usman "Oz" Azam, MD, President and Chief Executive Officer, and members of the management team plan to participate at two investor conferences in September and October 2019 (Press release, Tmunity Therapeutics, AUG 23, 2019, View Source [SID1234538963]).

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Citi’s 14th Annual Biotech Conference
Wednesday, September 4, 2019
Boston, MA

Chardan 3rd Annual Genetic Medicines Conference
Monday, October 7, 2019
Podium presentation at 2:00 p.m. ET
New York, NY

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

Genmab Announces Approval of DARZALEX® (daratumumab) in Frontline Multiple Myeloma in Japan

On August 22, 2019 Genmab A/S (Nasdaq: GMAB) reported that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) (Press release, Genmab, AUG 22, 2019, View Source [SID1234538928]). DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize the product. Genmab will receive a USD 7 million milestone payment from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label. The approval and related milestone do not impact the financial guidance issued by Genmab on August 14, 2019.

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"Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a DARZALEX containing regimen," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The approval is based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent in newly diagnosed ASCT ineligible multiple myeloma patients when daratumumab is combined with bortezomib, melphalan and prednisone. This data was presented as a Late-Breaking Abstract at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and published in The New England Journal of Medicine in December 2017.

About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study that included 706 newly diagnosed patients with multiple myeloma who are ineligible for ASCT. Patients were randomized to receive 9 cycles of either VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), once every three weeks from cycles 2 to 9, once every four weeks from cycle 9 until disease progression. The primary endpoint of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Approximately 6,313 new patients were expected to be diagnosed with multiple myeloma and approximately 4,338 people were expected to die from the disease in Japan in 2018.2 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.3 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.4

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).5,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.