Protalix BioTherapeutics to Hold Third Quarter 2018 Financial Results and Corporate Update Conference Call on November 7, 2018

On October 29, 2018 Protalix BioTherapeutics, Inc. (NYSE American:PLX, TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported that it will report third quarter 2018 financial results and provide a corporate update on Wednesday, November 7, 2018 at 8:30 am ET (Press release, Protalix, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373839 [SID1234530296]).

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To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 8567317.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

Principia Biopharma Appoints Dolca Thomas, M.D. as Chief Medical Officer

On October 29, 2018 Principia Biopharma Inc. (Nasdaq: PRNB), a clinical-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology, reported the appointment of industry veteran Dolca Thomas, M.D. as its Chief Medical Officer (Press release, Principia Biopharma, OCT 29, 2018, View Source [SID1234530295]). Dr. Thomas joins Principia from Roche, where she was Vice President and Global Head of Translational Medicine for Immunology, Inflammation, and Infectious Disease. She brings approximately 15 years of industry and medical experience to Principia. Steve Gourlay, MBBS, FRACP, Ph.D. will remain with the company as a senior medical advisor through mid-year 2019.

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"We are very excited with the addition of Dolca to the Principia team, particularly as we pursue an expanding scope of clinical development activities including initiating our pivotal Phase 3 trial for PRN1008 in patients with pemphigus. Dolca is a seasoned pharma executive with broad and successful experience in executing late stage programs, specifically in immunology," said Martin Babler, Chief Executive Officer of Principia. "I also want to thank Steve for his leadership, dedication and contributions to Principia over the past five years. Steve led the clinical development of three different molecules, including taking PRN1008 from its first-in-human trial through design and preparation for Phase 3. We are pleased that he will continue to support the company as a senior medical advisor through the first half of next year."

"I am impressed with Principia’s approach to BTK inhibition in autoimmune disease and believe that application of the company’s proprietary Tailored Covalency platform may be applicable across a wide range of autoimmune and inflammatory conditions," said Dr. Thomas. "I have been involved in more than a dozen immunology product candidates, and I look forward to contributing to the potential success of Principia’s pipeline assets and moving the company towards late-stage clinical development."

Dr. Thomas brings 15 years of industry and medical experience with strategic and operational responsibility for clinical development, pharmacovigilance, and safety and medical affairs of approximately two dozen pharmaceutical products. Most recently, Dr. Thomas was Vice President and Global Head of Translational Medicine for Immunology, Inflammation, and Infectious Disease at Roche, where she was responsible for advancing multiple product candidates through clinical development. Prior to Roche, Dr. Thomas held roles of increasing responsibility at Pfizer, including Vice President of Clinical Development and Clinical Immunophenotyping, and Vice President and Chief Development Officer of the Biosimilars Research and Development Unit where she was responsible for all stages of development of multiple assets. Dr. Thomas began her industry career at Bristol-Myers Squibb as Director of Global Clinical Development in Immunology, where she was involved in the development and approval of belatacept.

Dr. Thomas has a B.A. in sociology from Cornell University, and received her M.D. degree from Cornell University. Dr. Thomas completed her residency in internal medicine, in addition to her post-doctoral training in nephrology and transplantation, at New York- Presbyterian Hospital, Weill Cornell Medical Center.

Dr. Thomas represented both Bristol-Myers Squibb and Pfizer on the Board of Directors of the Progressive Multifocal Leukoencephalopathy (PML) Consortium, a cross-industry consortium aimed at identifying more effective methods of predicting, preventing, and developing future treatments for PML. Dr. Thomas has many past collaborations with the Juvenile Diabetes Research Foundation (JDRF) where she has been the recipient of multiple JDRF research grants and awards. In addition, she served on Board of Directors for the NYC JDRF chapter.

Vical Reports Third Quarter 2018 Financial and Operational Results

On October 29, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended September 30, 2018 (Press release, Vical, OCT 29, 2018, View Source [SID1234530293]). Net loss for the third quarter of 2018 was $1.5 million, or $0.07 per share, compared with a net loss of $3.1 million, or $0.27 per share, for the third quarter of 2017. Revenues for the third quarter of 2018 were $0.1 million, compared with revenues of $3.2 million for the third quarter of 2017, reflecting a reduction in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements. Net loss for the third quarter of 2018 included a gain of $2.3 million related to the sale of the Company’s manufacturing assets and $0.7 million received from Astellas to cover close down costs related to the ASP0113 program.

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Vical had cash, cash equivalents, marketable securities and long-term investments of $52.7 million at September 30, 2018. The Company’s cash burn for the third quarter of 2018 was $1.6 million. The Company is updating its 2018 full year cash burn guidance to a range of between $15 million and $18 million, a reduction in cash burn from its previous forecast of between $20 million and $24 million. The Company anticipates ending 2018 with a minimum of $45 million in cash, cash equivalents, marketable securities and long-term investments.

Vical recently announced plans to explore a range of strategic options to enhance shareholder value. The company retained MTS Health Partners, L.P. to assist in the strategic review process. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.

Program updates include:

VL-2397 Antifungal Candidate

The multinational Phase 2 registration trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. Centers are now open for enrollment in the US, Canada, Belgium, Germany, and will open shortly in South Korea. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.
VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018

Onconova Therapeutics to Meet with Potential Investors and Business Development Partners at the Bio-Europe 24th Annual International Partnering Conference in Copenhagen, Denmark

On October 29, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that Dr. Ramesh Kumar, CEO, will be meeting with potential Investors and Business Development partners at the 2018 Bio-Europe International Partnering Conference in Copenhagen (Press release, Onconova, OCT 29, 2018, View Source [SID1234530289]).

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Dates: Monday – Wednesday, November 5-7, 2018
Venue: Bella Center – Copenhagen, Denmark

Xencor to Host Third Quarter 2018 Financial Results Webcast and Conference Call on November 5, 2018

On October 29, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that it will release third quarter 2018 financial results after the market closes on Monday, November 5, 2018 (Press release, Xencor, OCT 29, 2018, View Source [SID1234530286]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers, and referencing conference ID number 5577136. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 90 days