Arena Pharmaceuticals to Present at the Evercore ISI HealthCONx Conference on December 1

On November 24, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, the Company’s President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the 3rd Annual Evercore ISI HealthCONx Conference on Tuesday, December 1, at 4:20 PM ET (Press release, Arena Pharmaceuticals, NOV 24, 2020, https://www.prnewswire.com/news-releases/arena-pharmaceuticals-to-present-at-the-evercore-isi-healthconx-conference-on-december-1-301179350.html [SID1234571690]).

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A live webcast of the presentation will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in Adults with Recurrent Glioblastoma Multiforme (GBM) and E-Poster Presentation at the Society for Neuro-Oncology (SNO) 2020 Virtual Meeting

On November 24, 2020 Celularity, Inc., a clinical-stage cell therapeutics company focused on the development of innovative allogeneic placenta-derived cellular therapies, reported that the first patient was dosed in its Phase 1 clinical study of human placental hematopoietic stem cell-derived natural killer cells (CYNK-001) in adults with recurrent glioblastoma multiforme (Press release, Celularity, NOV 24, 2020, View Source [SID1234571688]).

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"Celularity is committed to the development of innovative therapeutic tools to treat serious diseases, particularly targeting diseases with unmet medical needs that have a devastating impact on patients and families. As testimony to this commitment, we are extremely excited to announce the dosing of our first patient in our first clinical trial for, glioblastoma multiforme (GBM). Through the study team’s diligent efforts, we were able to rapidly complete the start-up activities and to accelerate the commencement of patient screening, enrollment, and first dosing in this important study," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and Chief Executive Officer.

This study (ClinicalTrials.gov Identifier: NCT04489420) will determine the maximum safe dose (MSD) of CYNK-001 which are culture-expanded NK cells derived from human placental CD34+ cells. The intravenous (IV) cohort will receive repeat administration of CYNK-001 cells after lymphodepleting chemotherapy. The intratumoral (IT) cohort will not receive lymphodepletion. The safety of this treatment will be evaluated, as researchers investigate the role of NK cells in the treatment of recurrent glioblastoma.

"Glioblastoma patients have poor survival and novel treatments are urgently needed for this patient population," said Nazanin Majd, M.D., Ph.D., assistant professor of Neuro-Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study. "Placental-derived NK cells are a promising approach in treatment of GBM patients as these cells have been shown to kill GBM tumor cells in pre-clinical animal studies. This trial offers an innovative immunotherapy approach where exogenously manufactured NK cells will be administered to GBM patients with the goal of shrinking the tumor and improving outcomes."

In a related development, the Company also announced that its abstract highlighting the details of this Phase 1 study was accepted for a poster presentation at the 25th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) which will occur November 19-21, 2020.

Presentation Details

Poster #:

RTID-07

Title:

HUMAN PLACENTAL HEMATOPOIETIC STEM CELL DERIVED NATURAL KILLER CELLS (CYNK-001) FOR TREATMENT OF RECURRENT GLIOBLASTOMA

Session:

Randomized Trials in Development

Authors:

Nazanin Majd, Maha Rizk, Solveig Ericson, Kris Grzegorzewski, Sharmila Koppisetti, Junhong Zhu, Lin Kang, Shawn He, Tanel Mahlakoiv, William van Der Touw, Xiaokui Zhang, Nassir Habboubi, Robert Hariri, Kathy Hunter, Kristin Alfaro-Munoz, Amy Heimberger, John de Groot, Linda Chi, Samer Srour

Dates:

Available November 19-21, 2020

Link:

View Source

About CYNK-001
CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

Phoenix Molecular Designs Announces First Patient Dosed in Phase 1b Clinical Trial of PMD-026 Taking Aim at Triple Negative Breast Cancer

On November 24, 2020 Phoenix Molecular Designs (PhoenixMD), an industry leader in the development of precise cancer therapeutics focusing on first-in-class RSK kinase inhibitors, reported that the first patient has been dosed in their Phase 1b clinical trial of PMD-026 (Press release, PhoenixMD, NOV 24, 2020, View Source [SID1234571687]). This RSK targeting trial is a first of its kind in the battle to combat the most aggressive subtype of breast cancer, known as Triple Negative Breast Cancer (TNBC), which claims the lives of thousands of patients each year. This patented small molecule, PMD-026, positions PhoenixMD in the lead to fill an unmet medical need as an effective treatment for this serious medical condition.

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This new trial comes at a critical time as, to date, durable treatment options for TNBC have been extremely limited. PhoenixMD’s lead asset, PMD-026, is the first purpose-built investigational drug specifically designed for TNBC. The company’s goal is to develop a therapy to treat TNBC that offers advantages over current approaches by taking aim at RSK, which is an entirely new drug target. PMD-026 is different from other therapies in that it is an oral capsule that can be taken at home rather than requiring an in-clinic or in-hospital administration. In addition, based on the data obtained in their Phase 1 clinical trial, PMD-026 was well-tolerated without hair loss or peripheral neuropathy, which are side effects of a number of other chemotherapy drugs. This data from their Phase 1 clinical trial of PMD-026 in metastatic cancer will be presented at the San Antonio Breast Cancer Conference Dec 8-12, 2020.

"Our mission is to improve the outcome for TNBC patients. This is a pivotal time for PhoenixMD; our extensive research to finding a path forward has reached the next important clinical milestone. PhoenixMD continues to aggressively pursue the clinical development of PMD-026 in an accelerated timeline while always ensuring that patient care is first and foremost in every decision that we make. As we begin our Phase 1b clinical trial, I am excited about the opportunity to bring this therapy, that uniquely targets the RSK pathway, to women with TNBC who participate in our clinical trial and who so desperately need help not provided by existing treatment options," said Sandra Dunn, Ph.D., Chief Executive Officer, PhoenixMD."

Initially, 20 TNBC patients will be enrolled in this Phase 1b expansion trial. As with the Phase 1 trial, this new trial will be conducted at leading medical centers across the United States.

"As a TNBC survivor, who was diagnosed at 34 years old, and patient advocate in the breast cancer community, I cannot emphasize enough how important this trial could be in the lives of so many. For a long time, there has been an utter lack of treatment options for this vulnerable breast cancer population," said Tara Coleman, Licensed Occupational Therapist, and Lymphedema Therapist. "Trials like this are urgently needed, and it is my hope that this trial proves to be a game-changer for the TNBC community. It has been my honor to work with Sandra and her team; the strides they have made coupled with their enthusiasm and commitment to patient advocate involvement and patient care has been truly incredible."

"Today’s announcement builds on PhoenixMD’s success with our Phase 1 clinical trial in metastatic cancer patients, which PhoenixMD completed in September of 2020," said F. Andrew Dorr, M.D., Chief Medical Officer, PhoenixMD. "At this pivotal time, I would like to recognize the PhoenixMD and SciQuus Oncology teams who have worked so diligently throughout the COVID-19 pandemic and the Phase 1 clinical trial. We are ready to meet the challenges and successes ahead in this next phase. I firmly believe that every step we take is a step closer towards finding a successful treatment for TNBC."

For more information about the Company’s Phase 1b clinical trial of PMD-026 in metastatic triple negative breast cancer, please visit www.clinicaltrials.gov (identifier NCT04115306).

China Biologic Reports Financial Results for the Third Quarter of 2020

On November 24, 2020 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 third quarter of 2020 (Press release, China Biologic Products, NOV 24, 2020, View Source [SID1234571686]).

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Third Quarter 2020 Financial Highlights

Total sales in the third quarter of 2020 increased by 0.8% in RMB terms and 1.8% in USD terms to $138.5 million from $136.1 million in the same quarter of 2019.
Gross profit increased by 4.4% to $92.5 million from $88.6 million in the same quarter of 2019. Gross margin increased to 66.8% from 65.1% in the same quarter of 2019.
Income from operations decreased by 1.9% to $52.0 million from $53.0 million in the same quarter of 2019. Operating margin decreased to 37.5% from 38.9% in the same quarter of 2019.
Non-GAAP adjusted income from operations increased by 11.7% in RMB terms and 12.8% in USD terms to $69.4 million from $61.5 million in the same quarter of 2019.
Net income attributable to the Company decreased by 16.0% to $39.5 million from $47.0 million in the same quarter of 2019. Diluted earnings per share decreased to $0.99 compared to $1.21 in the same quarter of 2019.
Non-GAAP adjusted net income attributable to the Company increased by 0.2% in RMB terms and 1.3% in USD terms to $55.1 million from $54.4 million in the same quarter of 2019. Non-GAAP adjusted earnings per diluted share was $1.39 compared to $1.40 in the same quarter of 2019.
NOTE: Detailed financial statements and information are available through this link: View Source

"This quarter China Biologic reported an encouraging rebound in revenue from the second quarter and a slight increase on a year-over-year basis, reflecting our efforts to regain sales momentum following the COVID-19 disruption," said Joseph Chow, Chairman and CEO of China Biologic. "Thanks to recent measures to improve sales and marketing efficiencies, we recorded non-GAAP operating income growth of nearly 12% over the same quarter last year. During the quarter we further optimized our commercial team structure, enhanced our medical marketing support function, implemented a multidimensional evaluation system for staff performance and established better incentive and compensation structures. These strategic initiatives position us to cope with ongoing pandemic-related macro-uncertainties as well as potentially intensifying market competition, in the face of a short-term decline in demand and supply surge as observed in our peer companies’ recent batch approval records."

"Beyond sales and marketing, our long term growth initiatives, including construction of new plasma collection stations and R&D projects, are well on track. We are pleased to report that our newly built collection station in Chongqing city recently passed official inspection with commercial operations to commence soon, and two new collection stations in Shandong province are expected to commercially launch in early 2021. With the continuing expansion of our plasma collection capacity and progress in our product pipeline, CBPO is well positioned to meet the increasing market demands for plasma protein therapeutics in China in the coming years."

Recent Development

As previously announced, on November 19, 2020, the Company entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with CBPO Holdings Limited ("Parent") and CBPO Group Limited ("Merger Sub"), a wholly owned subsidiary of Parent, which contemplates that Merger Sub will merge with and into the Company, with the Company continuing as the surviving entity and becoming a wholly-owned subsidiary of Parent.

Pursuant to the Merger Agreement, at the effective time of the merger, each ordinary share of the Company issued and outstanding immediately prior to the effective time of the merger will be cancelled and cease to exist in exchange for the right to receive $120.00 in cash without interest, except for Excluded Shares and Dissenting Shares (each as defined in the Merger Agreement). If completed, the merger will result in the Company becoming a privately-held company and its shares will no longer be listed on the NASDAQ Global Select Market.

The closing of the merger is currently expected to occur during the first half of 2021 and is subject to customary closing conditions, including, among others, (i) that the Merger Agreement shall be authorized and approved by an affirmative vote of shareholders representing at least two-thirds of the ordinary shares of the Company present and voting in person or by proxy at an extraordinary general meeting of the Company’s shareholders and (ii) that the aggregate amount of dissenting shares shall be less than 8% of the total outstanding ordinary shares of the Company immediately prior to the effective time of the merger.

The Company does not undertake any obligation to provide any update with respect to the merger or any other transaction, except as required under applicable law.

Conference Call

The Company’s management will hold a conference call at 7:30 a.m. ET on Wednesday, November 25, 2020, which is 8:30 p.m. Beijing Time on November 25, 2020, to discuss third quarter 2020 results. Listeners may access the call by dialing:

A telephone replay will be available one hour after the conclusion of the conference call through December 2, 2020. The dial-in details are:

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

Danaher To Present At Evercore ISI HealthCONx Conference

On November 24, 2020 Danaher Corporation (NYSE: DHR) reported that President and Chief Executive Officer, Rainer M. Blair, will be presenting at the Evercore ISI HealthCONx Conference on Tuesday, December 1, 2020 at 8:50 a.m. ET (Press release, Danaher, NOV 24, 2020, https://www.prnewswire.com/news-releases/danaher-to-present-at-evercore-isi-healthconx-conference-301180121.html [SID1234571683]). The audio will be simultaneously webcast on www.danaher.com.

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