Alder BioPharmaceuticals® to Host Conference Call to Discuss Fourth Quarter and Year-End 2017 Financial and Operating Results

On February 19, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will report its fourth quarter and year-end 2017 financial and operating results after the close of U.S. financial markets on Monday, February 26, 2018 (Press release, Alder Biopharmaceuticals, FEB 19, 2018, http://investor.alderbio.com/news-releases/news-release-details/alder-biopharmaceuticalsr-host-conference-call-discuss-fourth [SID1234524109]). Alder management will host a conference call and live audio webcast to discuss the results and provide a general business update at 5:00 p.m. ET the same day.

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The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 6943609. The webcast and any accompanying slides can be accessed from the Events & Presentations page in the investors section of Alder’s website at www.alderbio.com and will be available for replay following

BioCryst Pharmaceuticals and Idera Pharmaceuticals to Present at Two Upcoming Healthcare Investor Conferences

On February 19, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), reported they will be presenting at two upcoming healthcare-focused investor conferences (Press release, BioCryst Pharmaceuticalsa, FEB 19, 2018, View Source [SID1234524108]).

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The companies will be presenting at the RBC Capital Markets 2018 Global Healthcare Conference on Wednesday, February 21, 2018 at 3:05 P.M. E.T. The conference is being held at the Lotte New York Palace Hotel.

The companies will also be presenting at the 2018 Barclays Global Healthcare Conference on Tuesday, March 13, 2018 at 9:00 A.M. E.T. The conference is being held at the Lowes Miami Beach Hotel.

As a reminder, on January 22, 2018, BioCryst and Idera jointly announced the signing of a definitive merger agreement to combine into a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases. At the upcoming conferences, the companies will discuss the strategic initiatives of both companies, and how the combination of the two companies is expected to capitalize on the collective expertise and combined assets to create a comprehensive, sustainable rare disease-focused biotechnology leader.

Live audio webcast of these presentations will be accessible in the Investors and Media section of Idera’s website at View Source and in the Investors section of BioCryst’s website at http://www.biocryst.com. Archived versions will also be available on the respective Company’s websites after the events for 90 days.

Pieris Pharmaceuticals to Present at the RBC Capital Markets 2018 Global Healthcare Conference

On February 19, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that members of the management team will present at the RBC Healthcare Conference on Thursday, February 22, 3:35 pm EST at The New York Palace Hotel, New York City (Press release, Pieris Pharmaceuticals, FEB 19, 2018, View Source [SID1234524049]). A webcast of the Company’s presentation will be available at this link.

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MediciNova Announces Upcoming Presentation of the SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in Progressive MS at the American Academy of Neurology (AAN) 70th Annual Meeting in Los Angeles, California

On February 18, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that an abstract regarding the completed SPRINT-MS Phase 2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS), which was conducted through the National Institutes of Health (NIH)-sponsored NeuroNEXT network, has been selected for plenary presentation at the American Academy of Neurology (AAN) 70th Annual Meeting to be held April 21-27, 2018 in Los Angeles, California (Press release, MediciNova, FEB 18, 2018, View Source;p=RssLanding&cat=news&id=2333124 [SID1234524045]).

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The presentation entitled "A Phase II Trial of Ibudilast in Progressive Multiple Sclerosis" will be presented by Dr. Robert Fox, Staff Neurologist at the Cleveland Clinic and the principal investigator of this clinical trial.

Presentation details are as follows:

Date and Time: Tuesday, April 24, 2018, 9:15 am – 11:30 am

Session: Clinical Trials Plenary Session

Location: Los Angeles Convention Center, 1201 South Figueroa Street, Los Angeles, CA 90015

About the Progressive MS Trial

The Phase 2b Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) included 28 enrolling clinical sites across the U.S. and was designed to evaluate the safety, tolerability and activity of MN-166 (ibudilast) administered orally twice daily to subjects with primary progressive or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). 255 qualifying subjects were randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of up to 100 mg/day (50 mg twice daily). The progressive MS subjects were either untreated with long-term disease modifying therapy (DMT) or continued on either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment. Hence, randomization was controlled (stratified) by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study were to 1) evaluate the activity of ibudilast (MN-166) versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and 2) evaluate the safety and tolerability of ibudilast (MN-166) versus placebo in subjects with PPMS or SPMS. Additional measures included disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain. Exploratory objectives included pharmacokinetic and biomarker analyses.

About the Cooperative Effort

The collaborating entities include NeuroNEXT, the Cleveland Clinic, the National MS Society and MediciNova. NINDS’s Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations and industry. NeuroNEXT sites include many of the leading medical centers in the U.S. (www.neuronext.org). The goals of NeuroNEXT include testing of promising neurological therapies in Phase 2 clinical trials, optimizing drug development time and cost components through an established clinical trials infrastructure, and the coordination of public/private sector efforts by leveraging NINDS’s existing relationships with academic investigators and patient advocacy groups. A clinical coordinating center for NeuroNEXT is led by Dr. Merit Cudkowicz and is based at Massachusetts General Hospital and the data coordinating center is led by Dr. Chris Coffey at the University of Iowa. Principal Investigator Dr. Robert Fox and colleagues at the Cleveland Clinic collaborate with co-investigators at academic medical centers in the NeuroNEXT network. The National MS Society provided patient advocate input, trial enrollment awareness, and additional funding. MediciNova holds the trial IND with the FDA’s Division of Neurology Products and provides scientific and analytical support, as well as drug and placebo supply.

About Progressive Multiple Sclerosis

According to the National MS Society, MS affects approximately 2.3 million people worldwide. Approximately 85% of MS patients are initially diagnosed with relapsing remitting MS (RRMS). Most RRMS patients will eventually transition into SPMS in which there are fewer or no relapses but gradual worsening of neurologic function. Approximately 15% of MS patients are diagnosed with PPMS at onset and exhibit gradually increasing disability in walking, vision, mental acuity, and other bodily functions without experiencing relapses or remissions. Current therapies for MS affect the inflammatory response, but provide limited benefit for the neurodegeneration seen in progressive MS. There is a significant unmet medical need for agents that may provide neuroprotection in progressive MS.

About MN-166 (ibudilast)

MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.

Pipeline

Salarius’ lead molecule, Seclidemstat, is scheduled to begin enrollment for a Phase 1 trial in Ewing sarcoma in 2018. Ewing sarcoma is a devastating pediatric illness and represents a major unmet clinical need. Currently, chemotherapy, radiation and tumor resection surgery are the only options for patients, and in many cases the tumors reoccur or is in too delicate of a location to risk surgery. There is a 90% five-year mortality rate for patients whose tumors recur after treatment or who are initially diagnosed with metastatic disease. Translocations in the EWS protein are the sole driver for over 85% of Ewing sarcoma, and EWS must complex with LSD1 to induce a cancer phenotype. Seclidemstat blocks this LSD1 interaction to reverse cancer pathology resulting in cures in animal models.

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