MedX Health Corp. announces Third Quarter 2019 Results

On November 27, 2019 MedX Health Corp. ("MedX" or the "Company") (TSX-V: MDX) reported its results for the three and nine-months ended September 30, 2019, which are also available on SEDAR (www.sedar.com) (Press release, MedX Health, NOV 27, 2019, View Source [SID1234551762]).

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The Company reported revenue of $234,977 for the three months ended September 30, 2019, compared with revenue of $180,404 for the three months ended September 30, 2018. Revenues from the Company’s therapeutic laser line of $177,437 were 41% higher than in the prior year. SIAscopy revenues of $57,541 also showed improvement over the 2018 three-month period. The Company reported a loss for the three months ended September 30, 2019 of $577,648 or $0.00 per share compared with a loss of $919,935, or $0.01 per share for the three months ended September 30, 2018.

The Company reported revenue of $678,886 for the nine months ended September 30, 2019, compared with revenue of $812,233 for the nine months ended September 30, 2018. Revenues from the Company’s therapeutic laser line of $574,070 were up 13% for the nine-month period, while SIAscopy revenues were lower than the prior year. The Company reported a loss for the nine months ended September 30, 2019 of $2,086,892 or $0.01 per share compared with a loss of $3,171,333, or $0.02 per share for the nine months ended September 30, 2018.

"We experienced an increase in our SIAscopy product sales in Q3, a positive sign, with our Brazilian distribution partners participating in industry conferences and building the awareness level and interest in our DermSecure telemedicine platform by local dermatologists, as we get closer to regulatory approval in that country," noted Scott Spearn, CEO of MedX. "We expect to see further interest and increased revenue from the platform as we move into 2020, as the market realizes the benefits of our technology and how we can be a leader in shortening wait times, saving lives and lowering costs to the health care system. In addition, sales from our therapeutic laser products were solid again this quarter, up 41% over last year in Q3, and now 13% higher on a year-to-date basis."

Clover Biopharmaceuticals Completes $43 Million Series B Financing

On November 27, 2019 Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, reported the completion of a US$ 43 million (RMB 304 million) Series B financing (Press release, Clover Biopharmaceuticals, NOV 27, 2019, View Source [SID1234551764]). This financing round brings Clover’s total capital raised since 2016 to over US$ 100 million (over RMB 750 million).

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The Series B round was led by Delos Capital and Lapam Capital, with participation from Betta Capital, Sichuan Health Care Industry Fund, Beijing Zhongguancun VC and Jinlong Group. Concurrent with the financing, Mr. Tim Xiao, CFA, FRM, Principal of Delos Capital and Mr. Guangyu Xu, Partner of Lapam Capital, will join Clover’s board of directors. BFC Group served as exclusive financial advisor to Clover for the financing round.

The proceeds will support the continued clinical development of Clover’s biological candidates, operations of its new commercial-scale cGMP biomanufacturing facility, and expansion of its preclinical R&D pipeline utilizing its innovative and proprietary Trimer-Tag© technology platform. SCB-313, a novel TRAIL-Trimer fusion protein targeting intracavitary malignancies (malignant ascites, malignant pleural effusions, and peritoneal carcinomatosis), has initiated multiple Phase I clinical trials globally in both Australia and China. SCB-808, a proposed biosimilar of Enbrel (etanercept) being developed in the prefilled syringe formulation, is expected to enter Phase III clinical testing in 2019. Clover’s state-of-the-art 35,000m2 cGMP biomanufacturing facility, with initial 2 x 2,000 L bioreactor capacity, has completed construction and will support Clover’s clinical trials as well as future commercial production.

"As a research-based, science-driven biotechnology company, our mission has always been to bring our innovative biologic therapies to the world by leveraging our proprietary Trimer-Tag© drug development platform with global IP position, state-of-the art cGMP biomanufacturing capabilities, and passionate team of scientists and highly-experienced industry professionals," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We look forward to using the proceeds from this financing round to further accelerate our drug development and move closer to our goal of becoming the first truly-innovative global biologics R&D powerhouse founded in China."

"We are pleased to complete this financing round, as it will allow us to advance our lead biologic candidates into late-stage clinical development, expand our internal R&D capabilities and continue to build a world-class team," said Joshua Liang, Chief Strategy Officer and Board Director of Clover. "As one of the few global biotechnology companies based in China with both a truly innovative drug development platform and in-house cGMP biomanufacturing capabilities, we are pleased that renowned investors have recognized the potential of our company."

"We are proud to invest in Clover, which has made great strides in advancing its proprietary platform technology from concept to human clinical proof-of-concept and is targeting diseases of high unmet medical needs globally. We look forward to supporting the company in their development and also helping to create additional value from global collaborations," said Tim Xiao, Principal of Delos Capital.

"We are very impressed with Clover’s fully-integrated biologics development capabilities as well as its scientific team and technology platforms. We look forward to helping Clover bring their innovative and impactful medicines to market quickly and efficiently for the benefit of patients," said Guangyu Xu, Partner of Lapam Capital.

Arvinas to Present at the 31st Annual Piper Jaffray Healthcare Conference

On November 27, 2019 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Thursday, December 5 at 12:00 p.m. ET in New York, NY (Press release, Arvinas, NOV 27, 2019, View Source [SID1234551746]).

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A live audio webcast of the presentation will be available on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

Tyvyt (Sintilimab Injection), an Innovative PD-1 Inhibitor Jointly Developed by Innovent and Lilly, is Included in the New Catalogue of National Reimbursement Drug List (NRDL)

On November 27, 2019 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly") that the innovative PD-1 inhibitor Tyvyt (sintilimab injection), co-developed by both companies, is the only PD-1 inhibitor that has been included in the new Catalogue of National Reimbursement Drug List ("NRDL") according to the latest announcement from the National Healthcare Security Administration ("NHSA") (Press release, Innovent Biologics, NOV 27, 2019, View Source [SID1234551765]). (Details of medical insurance reimbursement and other relevant information shall be subject to the information publicized by the Chinese government.)

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The inclusion of Tyvyt (sintilimab injection) to the NRDL demonstrates that the NHSA has recognized its clinical value, patients benefit and novelty among other factors. This will also allow more patients to be able to afford the new immunotherapy drugs to improve their lives.

Dr. Michael Yu, Founder, Chairman and Chief Executive Officer of Innovent, said: "In recent years, the country’s healthcare system reform has been systematically promoting the ‘Healthy China’ strategy, to improve the health and well-being of ordinary people. We are glad to have such an opportunity and recognition from the government, making sintilimab the only anti-PD-1 monoclonal antibody drug to be included in the NRDL. Innovent’s mission is to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people. We will continue to work together with all relevant parties to improve drug efficacy, accessibility and affordability, which contributing to making a better and healthier life for ordinary people."

Mr. Julio Gay-Ger, President and General Manager of Eli Lilly China, said: "Tyvyt (sintilimab injection) is the first achievement of the strategic cooperation between Eli Lilly and Innovent, and its launch in the 1st half of this year has brought a new choice of immunotherapy for many patients. The negotiation to enter the NRDL is to improve the accessibility and further reduce the economic burden of patients. In the future, we will continue to deepen our cooperation with Innovent, and work together with all stakeholders to benefit Chinese patients through innovative drugs, healthcare services, flexible payment schemes and other innovative approaches."

Mr. Min Liu, Chief Commercial Officer and General Manager of Shanghai Branch of Innovent, said: "We believe that the inclusion of Tyvyt (sintilimab injection) in the NRDL will further help more cancer patients alleviate their economic burden and receive long-term and most advanced treatment. Next, we will actively respond to the requirements of government, work together closely to implement the medical insurance policies, and accelerate the accessibility of sintilimab in the hospital channel. We will also continue to explore innovative payment schemes with relevant parties, and strive to enable more patients to benefit from the scientific progress."

Tyvyt (Recombinant anti-human PD-1 Monoclonal Antibody, international trademark: Tyvyt, generic name: sintilimab injection) is an innovative PD-1 inhibitor jointly developed by Lilly and Innovent. It was officially approved by National Medical Products Administration ("NMPA") on 24 December 2018 and used for the treatment of relapsed or refractory classic Hodgkin’s lymphoma ("r/r cHL") after at least second-line system chemotherapy.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection), an innovative drug jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for r/r cHL, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology ("CSCO") for Lymphoid Malignancies. Tyvyt (sintilimab injection) is the only PD-1 inhibitor that has been included in the NRDL in November 2019.

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. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials. Innovent is also conducting clinical studies of sintilimab injection in the United States.

Phoenix Molecular Designs Announces $12 Million in Seed Financing

On November 27, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported that it has completed its most recent round of seed financing, resulting in a total raised to date of $12M (Press release, PhoenixMD, NOV 27, 2019, View Source [SID1234551550]). The primary use of funds continues to be on the preclinical and clinical advancement of its lead product candidate, PMD-026, a proprietary first-in-class orally-available RSK (kinase) inhibitor. PMD-026 is being developed as a platform technology to treat resistant forms of cancer, such as metastatic breast cancer and, more specifically, triple-negative breast cancer (TNBC).

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Investors in the financing round included Pallasite Ventures and World Changing Ventures.

"We are proud to help fund the PhoenixMD team in their mission to develop better therapeutic options for women with breast cancer," said Dr. Christopher Bissonnette, Managing Partner of Pallasite Ventures. "We believe PMD-026 is a promising new approach to treat advanced breast cancer, both as a monotherapy or in combination with chemotherapy. We are looking forward to working with the team and fellow investors to advance this important product into the clinic."

The company’s Phase 1/1b clinical trial is being conducted at leading medical centers across United States and it will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic breast cancer as well as a sub-group of women with TNBC. Importantly, this trial will include a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certified companion diagnostic (CDx) designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. Activated RSK2 is highly prevalent in breast cancer as it is expressed in approximately 89 percent of primary tumors. It is also detected in metastatic breast cancers, indicating that this drug target is retained in cancer cells that have moved to other parts of the body. The targeting of RSK2 by PMD-026, together with a validated CDx detecting activated RSK2 in tumors, create a distinct precision medicine approach to treating breast cancer.

"As a company in a challenging disease space, we appreciate the vote of confidence from our investors who join us in the pursuit of new medicines for patients with metastatic breast cancer," said Sandra Dunn, Ph.D., chief executive officer of Phoenix Molecular Designs. "Our seed funding has supported the early development of our lead product candidate, PMD-026, and we are delighted to have opened our Phase 1/1b clinical trial."

The advancement of PMD-026 in the company’s clinical trial is underscored by their teams’ impressive track record of market success in developing targeted therapies for breast cancer. Previously, this team has brought forward FDA-approved CDK4/6, PARP, ER and PIK3CA oral selective small molecule inhibitors. PhoenixMD looks forward to building upon this momentum in the pursuit of additional treatment options for individuals living with TNBC.

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. PMD-026 has begun Phase 1/1b clinical trials in the United States with the first site initiated at the end of October 2019.