On April 23, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has entered into definitive agreements with institutional investors to purchase an aggregate of 9,375,000 units at a public offering price of $1.60 per unit in a registered direct offering (Press release, Moleculin, APR 23, 2019, View Source [SID1234535328]). Each unit is comprised of one share of common stock and 0.5 of a warrant to purchase one share of common stock.

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Each warrant will have an exercise price of $1.75 per share and is exercisable immediately. The warrants will expire five years from the date of issuance. The shares of common stock and the accompanying warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about April 25, 2019, subject to customary closing conditions.

The gross proceeds of the offering are expected to be approximately $15.0 million, prior to deducting the placement agent fees and other estimated offering expenses.

Oppenheimer & Co. Inc. is acting as the sole placement agent for the offering. Roth Capital Partners, LLC and Maxim Group LLC are acting as financial advisors to the Company.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying prospectus forming part of a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 23, 2019 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 it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of glioblastoma (Press release, MediciNova, APR 23, 2019, View Source;p=RssLanding&cat=news&id=2395443 [SID1234535345]).

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Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than December 2037. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma using MN-166 (ibudilast) as part of a combination therapy. The allowed claims cover the use of MN-166 (ibudilast) with several types of combination therapies including laquinimod in addition to radiation therapy, electric field therapy, and various therapeutic agents such as temozolomide.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to receive notice that this new patent will be granted. We believe it could substantially increase the potential value of MN-166 as we recently initiated enrollment in a clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma (GBM) is a devastating brain cancer that typically results in death in the first 15 months after diagnosis. GBM develops from glial cells (astrocytes and oligodendrocytes) and rapidly grows and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents 15% of all brain tumors and 56% of all gliomas and has the highest number of cases of all malignant tumors, with approximately 12,000 new cases diagnosed each year. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with GBM. Median survival is 14.6 months and two-year survival is 30%. Approximately 5% of GBM patients survive longer than 36 months.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of progressive multiple sclerosis (MS) and other neurological diseases such as amyotrophic lateral sclerosis (ALS), glioblastoma (GBM) and substance abuse/addiction. MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS, glioblastoma, substance abuse/addiction and chemotherapy-induced neuropathy. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.

On April 23, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, reported that it has entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest (Press release, UroGen Pharma, APR 23, 2019, View Source [SID1234535329]). UroGen and Janssen will each conduct certain activities under the terms of the agreement.

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"We are excited to enter into this agreement with Janssen, an industry leader with a history of developing transformative therapies," said Liz Barrett, President and Chief Executive Officer of UroGen. "We maintain a strong commitment to bringing innovative treatments to patients in areas of unmet need."

On April 23, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the first quarter ending March 31, 2019 on Wednesday, May 1, 2019, before the U.S. financial markets open (Press release, Alnylam, APR 23, 2019, View Source [SID1234535346]).

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Management will provide an update on the Company and discuss first quarter 2019 results as well as expectations for the future via conference call on Wednesday, May 1, 2019 at 8:30 am ET. To access the call, please dial 800-289-0438 (domestic) or 323-794-2423 (international) five minutes prior to the start time and refer to conference ID 4935120. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 888-203-1112 (domestic) or 719-457-0820 (international) and refer to conference ID 4935120.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

On April 23, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, GlycoMimetics, APR 23, 2019, View Source [SID1234535330]). The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

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"The initiation of the NCI-sponsored trial is an important milestone for our uproleselan program, a drug candidate with the potential to address significant unmet treatment needs across the spectrum of AML," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice President, Clinical Development, and Chief Medical Officer. "Along with our global pivotal Phase 3 clinical trial testing the investigational drug in patients with relapsed/refractory acute myeloid leukemia, this trial will facilitate our growing understanding of how uproleselan may fit into the continuum of care for individuals living with AML."

GlycoMimetics is collaborating with both the NCI and the Alliance for Clinical Trials in Oncology to conduct the trial, which is led by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study. More information on this clinical trial can be found at www.clinicaltrials.gov.

New data on uproleselan-treated high-risk patients with both relapsed/refractory and newly diagnosed AML were presented at an oral session during the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018. An analysis of clinical outcomes from the Phase 1/2 clinical study showed that uproleselan (GMI-1271) resulted in the majority of evaluable patients achieving a stringent level of measurable residual disease (MRD) negativity, an effect which translated into extended survival relative to matched, historical controls.

About Uproleselan (GMI-1271)

uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is implementing a comprehensive development program across the clinical spectrum of AML.