China Biologic Reports Financial Results for the Second Quarter of 2019

On August 5, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the second quarter of 2019 (Press release, China Biologic Products, AUG 5, 2019, View Source [SID1234538148]).

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Second Quarter 2019 Financial Highlights

Total sales in the second quarter of 2019 increased by 20.4% in RMB terms and 12.7% in USD terms to $135.7 million from $120.4 million in the same quarter of 2018.
Gross profit increased by 9.9% to $90.9 million from $82.7 million in the same quarter of 2018. Gross margin decreased to 67.0% from 68.7% in the same quarter of 2018.
Income from operations increased by 34.3% to $48.2 million from $35.9 million in the same quarter of 2018. Operating margin increased to 35.5% from 29.8% in the same quarter of 2018.
Non-GAAP adjusted income from operations increased by 23.1% in RMB terms and 15.2% in USD terms to $56.7 million from $49.2 million in the same quarter of 2018.
Net income attributable to the Company increased by 55.2% in RMB terms and 45.5% in USD terms, to $41.6 million from $28.6 million in the same quarter of 2018. Fully diluted earnings per share increased to $1.06 compared to $0.83 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 29.1% in RMB terms and 21.1% in USD terms to $48.7 million from $40.2 million in the same quarter of 2018. Non-GAAP adjusted earnings per share increased to $1.24 from $1.17 in the same quarter of 2018.
"China Biologic continued to deliver solid financial results in the second quarter, driven primarily by higher-than-usual sales volumes of albumin and a high growth in sales volume for certain hyper-immunoglobulin products. However, IVIG sales remained sluggish, and the growth of albumin sales slowed down. While we closely monitor the impact of changes in the policy and market environment, we maintain our outlook for the year," said Joseph Chow, Chairman and CEO of China Biologic.

"As expected, the growth in albumin sales that we had experienced in the first quarter decelerated during the second quarter, reflecting the alleviation of the albumin supply shortage situation in the market due to relaxation of import constraints imposed in the earlier months of 2019. We expect growth in albumin sales to slow down further during the second half of the year, as a result of our relatively fixed level of annual production of albumin and the large volume of albumin which was oversold in the first half of the year. Sales of IVIG products during the second quarter still lagged behind our expectations, reflecting the continued negative impact of the policy controls on higher-unit-cost prescription drugs. Looking ahead, our polypeptide products may be included in China’s national and regional key drug lists for monitoring and prescription control, which we expect would significantly impact its sales. In addition, due to the increase of our account receivable turnover days relative to peer companies in the last two quarters, we have decided to begin a comprehensive review of our existing credit sale policies regarding pricing and credit terms, and to increase collection efforts to ensure our credit exposure is within the limits of our risk tolerance level. These measures could potentially impact our sales in the near term."

"In June, we obtained approval from the China National Medical Products Administration to begin human clinical trials on a Human von Willebrand Factor (VWF) product, which is intended to be used for the treatment of bleeding episodes including surgical bleeding in patients with von Willebrand disease. We expect that it will take approximately three years to complete the clinical trials. In late July, we received the operating permit for our new Wenchang plasma collection station in Hainan Province and immediately commenced commercial operations. We are also pleased to announce that in early August we completed the acquisition of the remaining 20% interest in TianXinFu and made it an indirect wholly-owned subsidiary of the Company, which will allow us to fully capture the growth potential of this leading player in the regenerative medical bio-material industry, better realize the synergies between TianXinFu’s business and China Biologic’s high-end coagulation factor business, and receive the full benefits and earnings accretion from existing and future TianXinFu products."

"Moving forward, with a stable and experienced team in place, we will continue our efforts to execute our sales and marketing strategies, including expanding our sales coverage and enhancing promotion of IVIG and high-end coagulation factor products to improve their prescription volumes in hospitals."

Appointment of Joseph Chow as CEO

The Company reported that its board of directors (the "Board") has appointed Mr. Joseph Chow as the CEO of the Company, effective August 5, 2019.

Mr. Chow is an experienced executive and has held managerial positions in various public and private companies. Mr. Chow has been a member of our Board since November 2014, our Chairman since February 2019 and our acting CEO since May 2019. After the departure of our former CEO in May 2019, the Board formed a search committee to seek a new CEO for the Company. After several months’ search and evaluation of both internal and external candidates, the search committee recommended Mr. Chow to the Board and the Board approved his appointment. The Board believes that, with his deep understanding of the Company and extensive experience in corporate finance and management, Mr. Chow is well qualified for the position and will lead the Company towards long-term sustainable growth.

Mr. Chow will continue to serve as a director and the Chairman of the Company. In order to fully devote to the affairs of the Company, Mr. Chow has resigned from all positions he previously held at Centurium Capital and no longer holds any interest in Centurium Capital or funds managed by it.

Mr. Chow stated, "I am thankful for the confidence and trust the Board has placed in me as the Company’s new CEO. I am looking forward to working with the management, employees and partners to redevelop the future roadmap for our business that charts its course and ensures long-term improved and sustainable growth."

Share Repurchase Program

In May 2019, the Board authorized a share repurchase program under which China Biologic may repurchase up to US$150 million worth of shares over a 12-month period. As of June 30, 2019, the Company had repurchased 121,852 shares at a total of $11.0 million under this program.

Second Quarter 2019 Financial Performance

Total sales in the second quarter of 2019 increased by 20.4% in RMB terms, or 12.7% in USD terms, to $135.7 million from $120.4 million in the same quarter of 2018.

Total sales for biopharmaceutical products (including plasma products and placenta polypeptide products) increased by 21.6% in RMB terms, or 14.0% in USD terms, to $122.3 million from $107.3 million in the same quarter of 2018, as a result of increased sales of human albumin products, certain hyper-immune products and coagulation factor products, which was partly offset by decreased sales of placenta polypeptide products. For plasma products, total sales in the second quarter of 2019 increased by 31.2% in RMB terms, or 22.8% in USD terms, to $111.0 million from $90.3 million in the same quarter of 2018.

Total sales for biomaterial products in the second quarter of 2019 increased by 9.9% in RMB terms, or 3.1% in USD terms, to $13.4 million from $13.0 million in the same quarter of 2018, as a result of higher sales concentration of higher-unit-price artificial dura mater products.

During the second quarter of 2019, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 36.9% in RMB terms, or 28.3% in USD terms, from $38.1 million in the second quarter of 2018 to $48.9 million in the second quarter of 2019. Revenue from IVIG products increased by 4.0% in RMB terms, or decreased by 2.5% in USD terms, from $28.1 million in the second quarter of 2018 to $27.4 million in the second quarter of 2019. As a percentage of total sales, sales from human albumin and IVIG products were 36.0% and 20.2%, respectively, in the second quarter of 2019.

Sales volume of human albumin products increased by 38.2% for the second quarter of 2019, primarily due to increased sales volumes in the distributor and pharmacy channels, supplemented by increased direct sales to hospitals and inoculation centers. The sales volume of IVIG products increased by 5.3% for the second quarter of 2019 as a result of increased sales through the direct sales channel.

The average prices for human albumin and IVIG products decreased by 0.9% and 1.2%, respectively, in RMB terms in the second quarter of 2019 compared to the same quarter of 2018 because of higher sales volume in the distributor channel and lower prices to certain distributors reflecting intensified market competition for major plasma products. In USD terms, the average price for human albumin and IVIG products decreased by 7.2% and 7.5%, respectively, in the second quarter of 2019 compared to the same quarter of 2018.

Revenue from other immunoglobulin products increased by 31.9% in RMB terms, or 23.5% in USD terms in the second quarter of 2019 compared to the same quarter of 2018, reaching 14.0% of total sales as compared to 12.8% of total sales in the same quarter of 2018. The revenue increase was mainly attributable to increased sales volume of human rabies immunoglobulin and human tetanus immunoglobulin products.

Revenue from other plasma products, including human coagulation factor VIII, human prothrombin complex concentrate, and human fibrinogen products, increased by 92.7% in RMB terms, or 80.5% in USD terms, in the second quarter of 2019 compared to the same quarter of 2018, representing 11.5% of total sales in the second quarter of 2019. The growth mainly came from increased sales through the distributor channel.

Revenue from placenta polypeptide products decreased by 29.0% in RMB terms, or 33.5% in USD terms for the second quarter of 2019 as compared to the same quarter of 2018, accounting for 8.3% of total sales compared to 14.1% of total sales in the second quarter of 2018, mainly in line with a decrease in sales volume as a result of the inclusion of placenta polypeptide products in regional adjuvant drug lists, which put a downward pressure on their prescription volume.

Cost of sales increased by 19.1% to $44.8 million in the second quarter of 2019 from $37.6 million in the same quarter of 2018. As a percentage of total sales, cost of sales increased to 33.0% from 31.2% in the same quarter of 2018, mainly due to decreased sales prices for most of the Company’s plasma products and increased plasma collection costs.

Gross profit increased by 9.9% to $90.9 million in the second quarter of 2019 from $82.7 million in the same quarter of 2018. Gross margin was 67.0% and 68.7% in the second quarter of 2019 and 2018, respectively.

Total operating expenses in the second quarter of 2019 decreased by $4.2 million, or 9.0%, to $42.7 million from $46.9 million in the same quarter of 2018. This decrease mainly consisted of a decrease of $5.9 million in general and administrative expenses, partially offset by an increase of $1.2 million in selling expenses and $0.5 million in research and development expenses. As a percentage of total sales, total operating expenses decreased to 31.5% in the second quarter of 2019 from 39.0% in the same quarter of 2018.

Selling expenses in the second quarter of 2019 increased by $1.2 million, or 4.9%, to $25.6 million from $24.4 million for the second quarter of 2018. The increase is primarily due to increased selling expenses for plasma products and biomaterial products, which is partly offset by a decrease in marketing and promotion expenses related to placenta polypeptide products. As a percentage of total sales, selling expenses decreased to 18.9% for the second quarter of 2019 from 20.3% in the same quarter of 2018.

General and administrative expenses in the second quarter of 2019 decreased by $5.9 million, or 28.6%, to $14.7 million from $20.6 million in the same quarter of 2018. As a percentage of total sales, general and administrative expenses decreased to 10.8% for the second quarter of 2019 from 17.1% for the same quarter of 2018. The decrease in general and administrative expenses was mainly because of a decrease in share-based compensation expenses and a reversal of allowance for doubtful accounts receivable.

Research and development expenses in the second quarter of 2019 increased by $0.5 million, or 26.3%, to $2.4 million from $1.9 million in the same quarter of 2018. As a percentage of total sales, research and development expenses increased to 1.8% from 1.6% in the same quarter of 2018.

Income from operations in the second quarter of 2019 increased by 43.4% in RMB terms, or 34.3% in USD terms, to $48.2 million from $35.9 million in the same quarter of 2018. Operating margin increased to 35.5% in the second quarter of 2019 from 29.8% in the second quarter of 2018.

Income tax expense in the second quarter of 2019 increased by 22.4%, to $8.2 million from $6.7 million in the same period of 2018. The effective income tax rate was 14.4% and 16.5% for the second quarter of 2019 and 2018, respectively.

Net income attributable to the Company increased by 55.2% in RMB terms, or 45.5% in USD terms, to $41.6 million in the second quarter of 2019 from $28.6 million in the same period of 2018. Net margin increased to 30.7% in the second quarter of 2019 from 23.8% in the same period of 2018. Diluted net earnings per share increased to $1.06 in the second quarter of 2019 compared to $0.83 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 23.1% in RMB terms, or 15.2% in USD terms, to $56.7 million in the second quarter of 2019 from $49.2 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 29.1% in RMB terms and 21.1% in USD terms, to $48.7 million in the second quarter of 2019 from $40.2 million in the same period of 2018. Non-GAAP net margin increased to 35.9% in the second quarter of 2019 from 33.4% in the same period of 2018. Non-GAAP adjusted net income per diluted share increased to $1.24 in the second quarter of 2019 from $1.17 in the same period of 2018.

Non-GAAP adjusted income from operations for the second quarter of 2019 excludes $6.5 million in non-cash employee share-based compensation expenses, and $2.0 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the second quarter of 2019 exclude $5.6 million in non-cash employee share-based compensation expenses, and $1.4 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

First Half 2019 Financial Performance

Total sales in the first half of 2019 increased by 21.3% in RMB terms, or 14.0% in USD terms, to $265.5 million from $232.8 million in the same period of 2018.

Total sales for biopharmaceutical products increased by 21.9% in RMB terms, or 14.5% in USD terms, to $238.7 million from $208.4 million in the same period of 2018, as a result of increases in the sales of human albumin products, immunoglobulin products and coagulation factor products, which was partly offset by decreases in the sales of placenta polypeptide products. For plasma products, total sales in the first half of 2019 increased by 33.4% in RMB terms, or 25.4% in USD terms, to $219.8 million from $175.3 million in the same period of 2018. As a percentage of total sales, sales from human albumin and IVIG products accounted for 39.8% and 21.3%, respectively, in the first half of 2019.

Total sales for biomaterial products in the first half of 2019 increased by 16.4% in RMB terms, or 9.4% in USD terms, to $26.7 million from $24.4 million in the same period of 2018, as a result of higher sales concentration in higher-unit-price artificial dura mater products.

Cost of sales increased by 24.8% to $89.0 million in the first half of 2019 from $71.3 million in the same period of 2018. As a percentage of total sales, cost of sales increased to 33.5% from 30.6% in the same period of 2018, mainly because of decreased sales prices for most of the Company’s plasma products, and increased plasma collection costs.

Gross profit increased by 9.3% to $176.5 million in the first half of 2019 from $161.5 million in the same period of 2018. Gross margin was 66.5% and 69.4% in the first half of 2019 and 2018, respectively.

Total operating expenses in the first half of 2019 decreased by $2.3 million, or 2.7%, to $84.4 million from $86.7 million in the same period of 2018. This decrease mainly consisted of a decrease of $2.7 million in general and administrative expenses and $0.6 million in selling expense, partially offset by an increase of $1.1 million in research and development expenses. As a percentage of total sales, total operating expenses decreased to 31.8% in the first half of 2019 from 37.2% in the same period of 2018.

Income from operations in the first half of 2019 increased by 30.9% in RMB terms, or 23.1% in USD terms, to $92.1 million from $74.8 million in the same period of 2018. Operating margin increased to 34.7% in the first half of 2019 from 32.1% in the first half of 2018.

Income tax expense in the first half of 2019 increased by $2.6 million, or 19.3%, to $16.1 million from $13.5 million in the same period of 2018. The effective income tax rate was 14.7% and 15.9% for the first half of 2019 and 2018, respectively.

Net income attributable to the Company increased by 40.2% in RMB terms, or 31.7% in USD terms, to $79.3 million in the first half of 2019 from $60.2 million in the same period of 2018. Net margin increased to 29.9% in the first half of 2019 from 25.9% in the same period of 2018. Diluted net earnings per share increased to $2.01 in the first half of 2019 compared to $1.75 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 16.7% in RMB terms and 9.7% in USD terms to $108.9 million in the first half of 2019 from $99.3 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 21.6% in RMB terms, and 14.3% in USD terms, to $93.2 million in the first half of 2019 from $81.6 million in the same period of 2018. Non-GAAP net margin remained comparatively stable at 35.1% in the first half of 2019 compared with 35.0% in the same period of 2018. Non-GAAP adjusted net income per diluted share was $2.36 and $2.37, respectively, in the first half of 2019 and 2018.

Non-GAAP adjusted income from operations for the first half of 2019 excludes $12.8 million in non-cash employee share-based compensation expenses, and $4.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the first half of 2019 exclude $11.1 million in non-cash employee share-based compensation expenses, and $2.8 million in amortization of intangible assets and land use rights related to the acquisition of TianXinFu.

As of June 30, 2019, the Company had $202.5 million in cash on hand and demand deposits, $523.9 million in time deposits, and $191.1 million in short term investments.

Net cash provided by operating activities for the first half of 2019 was $94.2 million as compared to $45.5 million for the same period of 2018. The $48.7 million increase in net cash provided by operating activities was a combined result of the increase in net income and a slowdown of increase in accounts receivable and inventories compared to the first half of 2018.

Accounts receivable increased by $15.2 million during the first half of 2019 as compared to $30.3 million during the same period of 2018. The accounts receivable turnover days for plasma products increased to 102 days during the first half of 2019 from 88 days during the same period of 2018, reflecting longer credit terms to hospitals as a result of the nationwide implementation of healthcare reform measures and intensified competition in the distributor channel.

Inventories increased by $4.3 million in the first half of 2019, which was milder than the increase of $21.4 million in the same period of 2018. This reflected a lower level of albumin inventory attributable to higher-than-expected albumin sales, which was partially offset by higher IVIG inventory due to sluggish IVIG sales.

Net cash used in investing activities for the first half of 2019 was $117.5 million as compared to $168.9 million for the same period of 2018. During the first half of 2019, the Company paid $15.1 million for the acquisition of property, plant and equipment, intangible assets and land use rights, and the Company also purchased time deposits and short-term investments in the amount of $1,265.0 million. This was partly offset by $1,162.7 million from the maturity of time deposits and short term investments. Net cash used in investing activities in the first half of 2018 mainly consisted of $529.6 million payment for purchase of time deposits and short term investments, and $19.1 million for the acquisition of property, plant and equipment, intangible assets, and land use rights, which was partly offset by $97.7 million cash received upon acquisition of TianXinFu and the maturity of $282.1 million time deposits and short term investments.

Net cash used in financing activities for the first half of 2019 was $114.9 million as compared to net cash provided by financing activities of $0.8 million for the same period of 2018. In the first half of 2019, $110.0 million was remitted to an investment bank by the Company to execute the previously approved share repurchase program on behalf of the Company. During this period, 1,196,228 shares were repurchased at a total amount of $111.0 million. Net cash provided by financing activities in the first half of 2018 represented proceeds of $0.8 million from stock options exercised.

Financial Outlook

The Company reiterates its forecast for the full year 2019. The company expects both non-GAAP adjusted income from operations and non-GAAP adjusted net income to increase by 4% to 6% in RMB terms over full year 2018 financial results.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.59 = $1.00 based on weighted average quarterly exchange rates in 2018 in translating 2018 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2019 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2019. This forecast reflects the Company’s current and preliminary views, which are subject to change.

Conference Call

The Company will host a conference call at 7:30 am Eastern Time on Tuesday, August 6, 2019, which is 7:30 pm Beijing Time on August 6, 2019, to discuss its second quarter 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through August 13, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10133955

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

Arcadia Biosciences Announces Date of Second-Quarter 2019 Financial Results and Business Highlights Conference Call

On August 5, 2019 Arcadia Biosciences, Inc. (Nasdaq: RKDA), a leader in science-based approaches to enhancing the quality and nutritional value of crops and food ingredients, reported its plan to release its second-quarter 2019 financial and business results after market close on August 14, 2019 (Press release, Arcadia Biosciences, AUG 5, 2019, View Source [SID1234538147]).

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The company has scheduled a conference call for 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss second-quarter results and the quarter’s key strategic achievements.

Interested participants can join the conference call using the following numbers:

U.S. Toll-Free Dial-In:

+1-844-243-4690

International Dial-In:

+1-225-283-0138

Passcode:

1488315

A live webcast of the conference call will be available in the Investors section of Arcadia’s website at www.arcadiabio.com. Following completion of the call, a recorded replay will be available on the company’s investor website.

Innovent and Shenogen Announce Collaboration to Evaluate Tyvyt® (Sintilimab injection) in Combination with SNG1005 for the Treatment of Patients with Advanced Cancer

On August 5, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported the signing of a collaboration agreement with Shenogen Pharma Group Ltd. ("Shenogen") to evaluate the combination therapy of Innovent’s Tyvyt (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody with Shenogen’s SNG1005, in patients with advanced cancer (Press release, Innovent Biologics, AUG 5, 2019, View Source [SID1234538146]).

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SNG1005 is a conjugate of angiopep-2 and paclitaxel that Shenogen licensed from overseas. Multiple Phase II clinical trials have been completed in the United States (U.S.), and its Phase III clinical trial protocol has been approved by the U.S. Food and Drug Administration (FDA). Shenogen has the full development and commercialization rights for SNG1005 in Greater China. Currently, the Investigational New Drug (IND) application of Phase II/III clinical trial for the treatment of breast cancer carcinoma brain metastases (BCBS) in China has been approved by the National Medical Products Administration (NMPA), and the clinical trial is planned. Tyvyt (sintilimab Injection) is the anti-PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company (Lilly). On 24 December 2018, Tyvyt (sintilimab Injection) was granted approval for market authorization by the NMPA for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).

Dr. Kun Meng, Chairman of Shenogen, commented, "The combined therapy of immune check point inhibitors and anti-tumor therapeutics has become the standard approach for the development of anti-tumor treatments. We are looking forward to close cooperation with Innovent in exploring the potential efficacy of anti-PD-1 inhibitor in combination with SNG1005. We are expecting the underlying synergistic effect in various cancers."

"SNG1005 is a first-in-class nab-paclitaxel therapeutic in development that can pass through blood-brain barrier (BBB), and we are very pleased to cooperate with Shenogen to explore the clinical synergistic efficacy with our PD-1 inhibitor. We hope to bring more clinical benefits to patients with advanced carcinomas," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About SNG1005

SNG1005, a conjugate of angiopep-2 and paclitaxel, binds to the low-density lipoprotein receptor-related protein 1 (LRP1). LRP1 is abundantly expressed on the Blood Brain Barrier (BBB), which facilitates efficient transcytosis movement of paclitaxel across the BBB. Besides its systemic effects, it can specially pass through the BBB and reach brain lesions.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

MOLOGEN AG Announces Top Line Data of Pivotal IMPALA Study in Metastatic Colorectal Cancer

On August 5, 2019 MOLOGEN AG (ISIN DE000A2LQ900, SIN A2L Q90) reported the top line data of its pivotal phase III IMPALA study (Press release, Mologen, AUG 5, 2019, View Source [SID1234538145]). The study compares the TLR9 agonist lefitolimod (MGN1703) with local standard of care as a maintenance therapy in patients with metastatic colorectal cancer presenting with an objective tumor response following first-line induction therapy. The primary endpoint – overall survival (OS) – was not met showing a median OS of 22.0 and 21.9 months in the lefitolimod and control group respectively (p=0.2765; HR=1.12; 95% CI 0.91 – 1.38). Timepoint related OS and predefined sub-group analyses did also not indicate a benefit, while regarding Progression Free Survival (PFS) standard of care was superior to lefitolimod treatment. No new safety signals were detected; hence the favorable safety and tolerability profile was confirmed.

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MOLOGEN is a pioneer in the field of immunotherapy, especially in the TLR9 field with the product family of DNA-based TLR9 agonists including its lead compound lefitolimod, as well as its follow-up molecules EnanDIM. Given its mode of action and confirmed favorable safety profile, lefitolimod is being used as combination partner in anti-cancer and anti-HIV immunotherapies.

Dr med Stefan M. Manth, CEO of MOLOGEN, noted: "We are disappointed with these top-line results and will now analyze the bountiful data coming out of IMPALA in depth. We will then build on these analyses from IMPALA to further inform the development of lefitolimod and its successor molecules from the EnanDIM platform for cancer and HIV patients. We are grateful to the patients and investigators for their participation in this important study."

Dr med Matthias Baumann, CMO of MOLOGEN, stated: "Unfortunately the positive results in our single agent lefitolimod phase II IMPACT study did not translate into a successful outcome of our phase III IMPALA trial despite the fact that all learnings have been incorporated into the trial design. In contrast to the time when the IMPALA design was conceived, it now appears that for successful anti-cancer immunotherapies a combination approach is of paramount importance. Due to the large body of evidence indicating the potential of TLR9 agonism in this context we remain committed to the further development of our candidates."

The detailed data from this first top line analysis of the IMPALA trial will be submitted for presentation at an upcoming international scientific congress.

Strategic focus on combination therapies in indications with high medical need and significant market potential

In light of these results the strategy of MOLOGEN going forward will focus on combination approaches for both lefitolimod and the first clinical candidate from the EnanDIM family in ongoing and planned clinical trials. This strategy serves as cornerstone for ongoing licensing and funding efforts.

Further to the IMPALA single-agent approach, lefitolimod is currently being evaluated in a phase I/II clinical study in combination with the checkpoint inhibitor Yervoy (ipilimumab) in a broader variety of solid tumors. The study is being conducted at the renowned MD Anderson Cancer Center, Texas, USA. In addition to studies in the field of oncology, lefitolimod has also been tested in HIV patients in a phase Ib/IIa study, the TEACH trial. Based on the encouraging study results, lefitolimod will be investigated in a phase IIa combination study, the TITAN trial, in HIV-infected patients in combination with innovative virus-neutralizing antibodies developed by the Rockefeller University in New York, USA. The trial will be conducted in cooperation with the Aarhus University Hospital in Denmark, which was also the academic partner of MOLOGEN in the TEACH trial. TITAN is funded by the US biotech company Gilead Inc. Furthermore, plans for another clinical combination study in HIV with a prominent US center are at an advanced stage.

The next generation TLR9 agonistic molecules of the EnanDIM-family coming out of the research labs of MOLOGEN offer additional potential for development in various cancer indications and HIV. A first clinical candidate from the EnanDIM platform is presently in late pre-clinical testing and expected to launch into clinical development in oncology at the end of 2019.

Checkpoint inhibitors alone are expected to generate sales of approximately US$ 25 billion by 2022 (acc. to Research and Markets) in a growing variety of indications. However, the greatest potential of checkpoint inhibitors is still to be realized, i.e. with adequate combination partners to target indications non-amenable to checkpoint inhibitor monotherapy. Estimates from the market research organization Research and Markets project that the market for cancer immunotherapies could rise to more than US$100 billion by 2024.

Background to the IMPALA study

IMPALA (Immunomodulatory MGN1703 in Patients with Advanced Colorectal Carcinoma with tumor reduction during induction treatment) is a pivotal, randomized, international, multicenter, open-label phase III trial. The study involves more than 540 patients from eight European countries, including the five major European pharmaceutical markets. Recruitment was completed in May 2017. The study includes patients with metastatic colorectal cancer who have responded to standard first-line treatment. Lefitolimod is subsequently administered subcutaneously 60 mg twice weekly as maintenance therapy. The primary endpoint is overall survival and secondary study endpoints include progression-free survival, safety and tolerability, as well as Quality of Life (QoL).

The study is conducted in collaboration with three highly profiled national collaborative study groups: Arbeitsgemeinschaft Internistische Onkologie (AIO) in Germany, Grupo Español de Tratamiento de Tumores Digestivos (TTD) in Spain and Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR) in France.

For more information on IMPALA please visit www.clinicaltrials.gov.

Enzo Biochem, Inc. Announces Issuance of United States Patent for Advanced Nucleic Acid Hybridization Probe Technology for Clinical and Research Applications

On August 5, 2019 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics and therapeutics company, reported the issuance of U.S. Patent No. 10,323,272 entitled Nucleic Acid Probes for In Situ Hybridization (Press release, Enzo Biochem, AUG 5, 2019, View Source [SID1234538144]). The patent is related to a new probe technology developed by Enzo and transformative methods of testing using the probes, which allow for significantly more cost effective, simple and scalable processes across the multi-billion dollar diagnostic testing, drug development and academic research marketplace.

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These new probes can be used to detect clinically relevant genomic targets with high-sensitivity in cell samples and biopsy tissue obtained from patients. Significantly, the new probe design permits the detection of such targets without the disadvantages encompassed in competing high-sensitivity methods such as nucleic acid amplification-based detection and branched DNA (bDNA) probe technologies, which can involve high cost, high complexity, time consuming processes and disruptions of sample integrity.

Elazar Rabbani, Ph.D., CEO of Enzo stated: "This is a transformative advance for Enzo and the industry. We are pleased to receive a U.S. patent for this new probe technology as we rapidly integrate it across our line of cytology and pathology products and services. With its superior sensitivity, simplicity of manufacturing and use, and superb performance in combination with Enzo’s PolyView line of detection reagents, we believe this new probe design will further drive Enzo’s business in existing in situ hybridization markets, such as HPV testing. We also believe it will enable a whole new range of applications for Enzo and its customers in the areas of tissue analysis, cancer diagnostics and liquid biopsy, as well as drug development and basic research."

The company is currently developing a next-generation, liquid cytology, Pap testing product as part of its women’s health platform, that employs the new probe technology for detecting genes of human papilloma viruses (HPV-16 and HPV-18) associated with cervical cancer. As the same viruses are also responsible for a growing number of oral and anal cancers, in both women and men, there may also be substantial further applications for these HPV probes.

Dr. Rabbani continued: "Because of its high-sensitivity signal amplification feature, we are also exploring non-in situ uses of this new probe design for the direct detection and quantification of nucleic acids of interest, including very low quantity targets where previously only nucleic acid amplification based techniques that copy the target, such as the Polymerase-mediated Chain Reaction (PCR), were practical."