On March 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the closing of its previously announced underwritten public offering of 16,666,668 shares of common stock, short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75 per share and accompanying warrants (Press release, Oragenics, MAR 25, 2019, View Source [SID1234534633]).

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Oragenics expects to receive gross proceeds of approximately $12.5 million from the offering.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

Each short-term warrant has an exercise price of $0.75 per share of common stock, is immediately exercisable, and will expire on the earlier of (1) the eighteen-month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant has an exercise price of $0.90 per share of common stock, is immediately exercisable and will expire five years following the date of issuance.

The Company has granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions. The underwriter exercised its option to purchase the short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock effective as of the closing.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016, and additional registration statement filed pursuant to Rule 462(b) (File No. 333-230422). A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

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

On March 25, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into an agreement with funds managed by Oberland Capital Management, LLC ("Oberland Capital") for up to $135.7 million in exchange for selling rights to a portion of royalty revenues on worldwide net sales of Erivedge (Press release, Curis, MAR 25, 2019, View Source [SID1234534632]).

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Under the terms of the agreement, Curis received $65.0 million in an upfront cash payment, plus Curis is entitled to receive up to an additional $70.7 million in milestone payments if future net royalties exceed pre-defined annual and cumulative thresholds. Oberland Capital will receive 100% of the first $13.2 million and 35% thereafter of annual net royalties due to Curis from worldwide net sales of Erivedge, excluding a portion of non-US royalties retained by Curis. At the closing of the transaction, Curis used a portion of the sale proceeds to retire existing debt, with remaining proceeds of approximately $30 million, excluding closing costs and related transaction fees, to be used to fund its operations.

James Dentzer, President & CEO of Curis, commented, "We are pleased to announce this agreement with Oberland Capital. We believe this structure provides Curis with substantial non-dilutive capital today, while retaining significant participation in the future upside potential of Erivedge. The proceeds of this transaction further strengthen our cash position as we fund our three lead therapeutic candidates to reach their near term development catalysts and beyond."

"Erivedge is an attractive asset commercialized by a world-class marketer and we are pleased to partner with Curis as it advances its clinical pipeline" said Andrew Rubinstein, Managing Partner of Oberland Capital. "Acquiring a participation in Erivedge royalties reflects our strategy of investing in commercial stage or near-commercial stage biopharmaceutical products that address serious diseases or areas of high unmet medical need."

About Erivedge
Erivedge (vismodegib) is a first-in-class orally-administered small molecule which is designed to selectively inhibit the Hedgehog signaling pathway by targeting a protein called Smoothened. Genetic mutations that lead to unregulated activation of Hedgehog signaling are found in basal cell carcinoma (BCC) and medulloblastomas. Aberrant signaling in the Hedgehog pathway is implicated in over 90% of BCC cases. Erivedge is being developed and commercialized by Roche and Genentech under a 2003 collaboration agreement between Curis and Genentech whereby Genentech obtained an exclusive, global, royalty-bearing license with the right to sublicense, to make, use, sell and import small molecule and antibody Hedgehog pathway inhibitors for human therapeutic applications, including cancer therapy. Erivedge is approved for use in patients with advanced basal cell carcinoma in the U.S. and over 60 foreign countries. It is also under regulatory review for commercialization in a number of additional territories.

On March 25, 2019 BioXcel Therapeutics, Inc. ("BTI") (BTAI) reported that it has filed a Clinical Trial Application (CTA) with the U.K. health authorities for its lead immuno-oncology asset, BXCL701, an orally-available small molecule immune-modulator with dual mechanisms of action, in combination with pembrolizumab (Keytruda), a checkpoint inhibitor, in tNEPC (Press release, BioXcel Therapeutics, MAR 25, 2019, View Source [SID1234534627]). BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.

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Following approval of the CTA, BTI plans to expand the Phase 1b/2 US study of BXCL701 and pembrolizumab in tNEPC to the U.K. Professor Johann de Bono, M.D., Ph.D., of The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, will serve as Principal Investigator for the European study of BXCL701 in tNEPC. Data from the open-label trial will support the ongoing global clinical development of BXCL701.

Additionally, BioXcel Therapeutics is preparing to file an Investigational New Drug (IND) application with the FDA for a clinical trial evaluating the triple combination of BXCL701, NKTR-214 and avelumab in the treatment of advanced pancreatic cancer.

Dr. Chetan D. Lathia, SVP & Head of Translational Medicine, Clinical Pharmacology and Regulatory Affairs of BTI said, "The filing of the CTA in the U.K., for the BXCL701 combination trial is an important regulatory milestone for BTI. It marks the beginning of our plans for the global development of our lead programs."

Dr. Vimal Mehta, Chief Executive Officer of BTI added, "We remain committed to translating the potential of BXCL701’s novel mechanism of action into therapies that can fundamentally change the lives of cancer patients. The filing of this CTA is the first milestone in the expansion of our footprint into major markets outside the US. We believe that our pancreatic cancer clinical development partnership with Nektar, Pfizer and Merck KGaA, Darmstadt, Germany will also benefit the broader BXCL701 program."

The Company also announced that Professor de Bono has joined its Immuno-oncology Clinical Advisory Board. Professor De Bono is the Regius Professor of Cancer Research and a Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust. He is also the Director of the Drug Development Unit, overseeing the Phase I trials, with a particular interest in innovative trial designs, circulating biomarkers and prostate cancer. Additionally, he leads the Prostate Cancer Targeted Therapy Group and the Cancer Biomarkers laboratory team. He has served as chief investigator on trials for multiple approved drugs, including ZYTIGA, JEVTANA and XTANDI.

Professor de Bono is a clinical investigator in the KEYNOTE- 199 trial, a study evaluating Pembrolizumab in docetaxel pre-treated castrate-resistant metastatic prostate cancer patients. He graduated with a medical degree and a postdoctoral degree from University of Glasgow. He also trained in medical oncology and was awarded a master’s degree in cancer sciences from the University of Glasgow. Professor de Bono has received multiple awards including one of the "World’s Most Influential Scientific Minds," the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) award and the Royal Society of Chemistry award.

About BXCL701

BXCL701 is an orally-available systemic innate-immune activator with dual mechanisms of action. It has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. BXCL701’s primary mechanism of action has recently been highlighted in multiple peer reviewed journals, providing an important validation of the scientific rationale behind BXCL701.

On March 25, 2019 NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) reported that the English version of the Annual report for 2018 is now available on the company’s website www.neurovive.com (Press release, NeuroVive Pharmaceutical, MAR 25, 2019, View Source [SID1234534616]).

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This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 10:00 a.m. CET on 25 March 2019.

On March 25, 2019 Aprea Therapeutics, a clinical-stage biotechnology company developing novel anticancer therapies targeting the p53 tumor suppressor protein, reported the appointment of Dr. Eyal C. Attar as Senior Vice President and Chief Medical Officer (Press release, Aprea, MAR 25, 2019, View Source [SID1234534615]). A trained physician in medical hematology and oncology, Dr. Attar brings nearly 20 years of medical research and clinical development experience to Aprea.

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"Dr. Attar’s deep medical and biotech industry experiences will strengthen our clinical development efforts as we continue to advance our first-in-class p53 reactivating agents in late-stage clinical studies," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "His proven leadership and focus on improving outcomes for patients with limited therapeutic alternatives is an excellent fit with Aprea’s determined strategy to advance novel oncology therapies."

"I am thrilled to join the Aprea team at this exciting time in the company’s evolution," said Dr. Attar. "I believe Aprea’s leading scientific approach in reactivating the mutated tumor suppression gene, p53, represents a new paradigm in anti-cancer treatment and a promising novel therapeutic approach for patients for whom there is tremendous need."

Dr. Attar joins Aprea from Agios Pharmaceuticals, where he was Senior Medical Director and IDH Hematology Medical Lead. Having served at Agios since 2014, Dr. Attar played a leadership role in the clinical development and approval of IDHIFA and TIBSOVO for patients with relapsed/refractory AML. Prior to Agios, he served on the clinical staff at the Massachusetts General Hospital Cancer Center, where Dr. Attar was a member of the Center for Leukemia and Assistant Professor of Medicine at Harvard Medical School. He completed his residency in Internal Medicine at Brigham and Women’s Hospital and held fellowships in hematology and oncology in the Dana-Farber Partners Cancer Care Hematology/Oncology Fellowship Program. Dr. Attar received his medical degree from the University of North Carolina School of Medicine.