On September 5, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that bind specifically to the A3 adenosine receptor (A3AR), addressing cancer, liver and inflammatory diseases, reported the Company’s CEO Dr. Pnina Fishman will present at the H. C. Wainwright 21st Annual Global Investment Conference to be held on September 8-10, 2019 at the Lotte New York Palace Hotel in New York City (Press release, Can-Fite BioPharma, SEP 5, 2019, https://ir.canfite.com/news/detail/864/can-fite-to-present-at-h-c-wainwright-21st-annual-global-investment-conference-on-september-10-2019 [SID1234539298]).

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Dr. Fishman will present on Tuesday, September 10th at 3:00 p.m. in the Kennedy I room, 4th floor. Company executives will also conduct one-on-one meetings with institutional investors.

On September 5, 2019 Selvita (WSE: SLV) reported second quarter 2019 financial results and provided a corporate update (Press release, Selvita, SEP 5, 2019, View Source [SID1234539281]).

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"We continue to execute on the priorities we set out early in the year," commented Pawel Przewiezlikowski, Chief Executive Officer of Selvita. "We expect to see our oncology therapeutics and research services divisions operate as independent public companies in the fourth quarter of 2019, and our portfolio programs continue to advance as expected. Dosing of the first patient in our Phase 1 study of CDK8 inhibitor SEL120 is expected in the third quarter of 2019 and we expect to select an additional candidate to advance into clinical development by the end of 2019."

Recent Achievements

In June, a poster relating to the Phase 1/2 study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase discovered by Selvita, was presented at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (Abstract PF281).
In June, a poster relating to the Phase 1/2 study of SEL24/MEN1703 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract TPS7062).
Selvita Oncology Second Quarter and Six Months Ended June 30, 2019 Financial Results

Operating loss (EBITDA excluding IFRS16 impact) for the quarter ended June 30, 2019, was $(2.7) million, compared to net loss of $(0.8) million for the quarter ended June 30, 2018. Revenues attributable to non-dilutive grant sources were $2.1 million for the quarter ended June 30, 2019, compared to grant revenues of $1.6 million for the quarter ended June 30, 2018. Research and development expenses were $5.0 million for the quarter ended June 30, 2019, an increase of $1.8 million, compared to $3.2 million for the same period ended June 30, 2018. The increase in research and development expenses was primarily attributable to the fact that the Group strongly focuses on the development of its own research projects and preparing them for commercialization at the later stages of development.

Operating loss (EBITDA excluding IFRS16 impact) for the six months ended June 30, 2019, was $(4.9) million, compared to net loss of $(1.4) million for the quarter ended June 30, 2018. Revenues attributable to non-dilutive grant sources were $4.1 million for the six months ended June 30, 2019, compared to grant revenues of $2.7 million for the six months ended June 30, 2018. Research and development expenses were $9.5 million for the six months ended June 30, 2019, an increase of $4.0 million, compared to $5.5 million for the same period ended June 30, 2018.

At June 30, 2019, Selvita Oncology held $20 million in cash, cash equivalents, and short-term investments.

Selvita CRO Second Quarter and Six Months Ended June 30, 2019 Financial Results

Research Services revenues for the quarter ended June 30, 2019, were $5.5 million, an increase of $1.3 million compared to revenues of $4.2 million for the quarter ended June 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $1.2 million for the quarter ended June 30, 2019, as compared with $0.9 million for the same period ended June 30, 2018.

Research Services revenues for the six months ended June 30, 2019, were $10.4 million, an increase of $2.2 million compared to revenues of $8.2 million for the quarter ended June 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $2.1 million for the quarter ended June 30, 2019, as compared with $1.8 million for the same period ended June 30, 2018.

On September 4, 2019 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on rare brain and solid tumors, reported that it will feature a clinical poster presentation at the National Organization for Rare Disorders’ (NORD) Rare Disease and Orphan Products Breakthrough Summit taking place October 21-22, 2019 in Washington, D.C. at the Marriott Wardman Park (Press release, Bexion, SEP 4, 2019, View Source [SID1234539354]).

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NORD Annual Meeting
The NORD Annual Meeting brings together approximately 1000 multi-stakeholders in the rare disease community including Senior FDA officials, advocacy/patient groups, bio/pharma and solution services professionals.

First-in-human, First-in-class
Bexion’s poster is entitled, "First-in-human, First-in-class Phase 1 Study of BXQ-350 for Solid Tumors and Gliomas," and includes updated clinical information from the original poster presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, 2018.

Strong Safety and Tolerability
"This Phase 1 study of BXQ-350 demonstrated a strong safety and tolerability profile for a first-in-class, novel approach to treating brain and solid tumors," said Ray Takigiku, CEO and President of Bexion. "We are also highly encouraged by the evidence of possible clinical activity in some of our patients and are excited to explore the potential of this compound in future clinical trials."

On September 4, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported the following two new additions to its senior leadership team (Press release, Synlogic, SEP 4, 2019, View Source [SID1234539307]):

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Richard Riese, M.D., Ph.D., has been appointed to the position of Chief Medical Officer, and will assume responsibilities from current president and CEO, Aoife Brennan, M.B., Ch.B.
Michael Slater, a former consultant to the Company, has been appointed to Head of Regulatory Affairs.
Separately, the company is announcing the departure of Todd Shegog, Chief Financial Officer, effective September 18, 2019.

"Richard and Michael bring expertise and many years of experience across all phases of clinical development in a broad range of rare and immunologically-based diseases, which will be key to Synlogic’s success as we advance and expand our Synthetic Biotic therapeutic platform," said Dr. Brennan. "We are excited to welcome them both to the team and look forward to their contributions."

"Synlogic is a leader in developing engineered bacteria as living medicines and has demonstrated its ability to advance these novel therapeutics into clinical trials," stated Dr. Riese. "I believe that its Synthetic Biotic platform has the potential to provide a novel therapeutic solution to address unmet medical need in a variety of conditions and I look forward to advancing this exciting new therapy to patients."

Dr. Riese is a physician scientist with over 15 years of experience in the pharmaceutical industry. He most recently served as Vice President, Clinical Development at Alnylam where he led clinical development projects in several areas across Alnylam’s rare disease portfolio. Previously, he served as head of Translational Clinical Sciences in the Research Unit at Alexion, where he was responsible for the clinical development strategy of all compounds from discovery to proof-of-concept. He earned a Ph.D. in biophysics and an M.D. from the Medical College of Wisconsin, and a B.S. in mathematics from the University of Wisconsin-Madison. Dr. Riese carried out postdoctoral research at the Medical College of Wisconsin and his residency training in internal medicine at Brigham and Women’s Hospital in Boston. Dr. Riese achieved certification by the American Boards of Pulmonary Medicine, Critical Care Medicine and Internal Medicine.

Mr. Slater is a senior level regulatory professional with more than 25 years of experience including hands-on preclinical and clinical regulatory strategy development from pre-investigational new drug (IND) application through drug approval. Mr. Slater was the Head of Regulatory Affairs and later, Development Operations at Merrimack Pharmaceuticals from 2010 to 2019. At Merrimack, Mr. Slater led the regulatory strategy resulting in the 2015 U.S. approval of Onivyde (irinotecan liposome injection), an orphan drug for the treatment of metastatic pancreatic cancer. In addition, he worked with Baxalta who acquired certain ex-US rights to Onyvide, to achieve approval in Europe and other countries. Prior to Merrimack, Mr. Slater held various regulatory roles in several biotech and pharmaceutical companies, including Millennium Pharmaceuticals, Acusphere, Inc., Anika Therapeutics, Inc., ImmuLogic Pharmaceuticals, Biogen and Hoechst Pharmaceuticals. With a background in applied biology, Mr. Slater also holds a B.Sc. in information science from Leeds Beckett University, UK. and is a Fellow of The Organization for Professionals in Regulatory Affairs.

In addition, the Company is announcing the departure of Todd Shegog, Chief Financial Officer, who is leaving the company to pursue another opportunity. The Company has commenced a search for a new CFO.

"I also want to take the opportunity to thank Todd for his contributions at Synlogic over the past three years, including leading us through the process of becoming a public company, and establishing a strong financial team and our internal controls and financial operations," said Dr. Brennan. "We have appreciated his leadership and wish him all the best in his future endeavors."

On September 4, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will attend the Morgan Stanley Global Healthcare Conference on Wednesday, September 11, 2019. Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, will participate in a fireside chat at 1:00 p.m., Eastern Time (Press release, Eli Lilly, SEP 4, 2019, View Source [SID1234539303]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.