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Exicure Announces Proposed Public Offering of Common Stock

On December 18, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Exicure, DEC 18, 2019, View Source [SID1234552519]). In addition, Exicure intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of its common stock offered in the public offering. All of the shares are being offered by Exicure. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to initiate a second arm in its Phase 1b/2 clinical trial in cutaneous squamous cell carcinoma; to develop an SNA-based therapeutic candidate for the treatment of Friedreich’s ataxia, initiate IND-enabling studies and advance it into Phase 1 clinical trials; to develop a second SNA therapeutic candidate for a neurology condition and initiate IND-enabling studies; and for general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering.

The securities described above are being offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 that state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

Epizyme Announces FDA Advisory Committee Votes Unanimously in Favor of Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 11 – 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surgery (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552518]).

"We are incredibly pleased by ODAC’s unanimous support of the benefit-risk of tazemetostat in ES, and we appreciate the tremendous support received from sarcoma physicians and their medical teams, advocates, caregivers and most notably, patients with ES," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "We believe the strength of the totality of data, including the observed durable responses and stabilization of disease, safety and tolerability, are distinguishing characteristics of tazemetostat for patients living with this disease. We are thrilled by the panel’s support and look forward to working closely with the Agency as they continue their review of our NDA. I am confident that we have submitted a comprehensive clinical data package for ES to support tazemetostat’s approval."

ES is a rare and aggressive soft tissue sarcoma characterized by a loss of the INI1 protein. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age, typically with no patients living past five years from diagnosis. ES becomes more aggressive after recurrence or once it has metastasized, with a typical survival of less than one year for patients with metastatic disease.

"Today’s ODAC outcome is a significant step toward addressing the critical needs of ES patients," said Robert Bazemore, president and chief executive officer of Epizyme. "This is a remarkable achievement marking the culmination of years of hard work by the entire Epizyme team. If approved, we will have the opportunity to change how patients with this devastating cancer are treated. Our commercial-readiness is complete, and we look forward to finalizing our dialog with the FDA."

The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. The New Drug Application (NDA) for tazemetostat, an investigational, oral, first-in-class EZH2 inhibitor, is currently under Priority Review by the FDA with a PDUFA target action date of January 23, 2020. Epizyme’s NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat, which were reported at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.

BIOGEN TO REPORT FOURTH QUARTER AND YEAR-END 2019 FINANCIAL RESULTS JANUARY 30, 2020

On December 18, 2019 Biogen Inc. (Nasdaq: BIIB) reported it will report fourth quarter and year-end 2019 financial results Thursday, January 30, 2020, before the financial markets open (Press release, Biogen, DEC 18, 2019, View Source [SID1234552512]).

Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

Entry into a Material Definitive Agreement

On December 18, 2019 Exelixis, Inc. ("Exelixis") reported that it has entered into a joint clinical research agreement (the "Clinical Collaboration Agreement") with F. Hoffmann-La Roche Ltd. ("Roche") for the purpose of evaluating the combination of cabozantinib (CABOMETYX) with atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic solid tumors, including in three planned phase 3 pivotal trials in advanced non-small cell lung cancer, castration-resistant prostate cancer and renal cell carcinoma (Filing, 8-K, Exelixis, DEC 18, 2019, View Source [SID1234552502]). If a party to the Clinical Collaboration Agreement proposes any additional combined therapy trials beyond the initial three planned phase 3 pivotal trials, the Clinical Collaboration Agreement provides that such proposing party must notify the other party and that if agreed to, any such additional combined therapy trial will become part of the collaboration, or if not agreed to, the proposing party may conduct such additional combined therapy trial independently, subject to specified restrictions set forth in the Clinical Collaboration Agreement.

Pursuant to the terms of the Clinical Collaboration Agreement, each party granted to the other a non-exclusive, worldwide (excluding, in the case of Exelixis, territory already the subject of a license by Exelixis to Takeda Pharmaceutical Company Ltd.), non-transferable, royalty-free license, with a right to sublicense (subject to limitations), to use the other party’s intellectual property and compounds solely as necessary for the party to perform its obligations under the Clinical Collaboration Agreement. The parties’ efforts will be governed through a joint steering committee established to guide and oversee the collaboration and the conduct of the combined therapy trials. Each party will be responsible for supplying drug product for all combined therapy trials, and the cost of such drug product supply will be borne by such party. The clinical trial expenses for each combined therapy trial agreed to be conducted jointly under the Clinical Collaboration Agreement, including the initial three planned phase 3 pivotal trials, will be shared equally between the parties, and the clinical trial expenses for each additional combined therapy trial not agreed to be conducted jointly under the Clinical Collaboration Agreement will be borne by the proposing party, except that the cost of drug product supply for all combined therapy trials will be borne by the party that owns the applicable drug product.

Unless earlier terminated, the Clinical Collaboration Agreement provides that it will remain in effect until the completion of all combined therapy trials under the collaboration, the delivery of all related trial data to both parties, and the completion of any then agreed-upon additional analyses. The Clinical Collaboration Agreement may be terminated for cause by either party based on any uncured material breach by the other party, bankruptcy of the other party or for safety reasons. Upon termination by either party, the licenses granted to each party will terminate upon completion of any ongoing activities under the Clinical Collaboration Agreement.
The description of the Clinical Collaboration Agreement in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Clinical Collaboration Agreement, a copy of which will be included as an exhibit to Exelixis’ Annual Report on Form 10-K for the fiscal year ending January 3, 2020, to be filed with the Securities and Exchange Commission.

Monopar Therapeutics Inc. Announces Pricing of Initial Public Offering

On December 18, 2019 Monopar Therapeutics Inc. reported that it has priced an initial public offering of 1,111,112 shares of its common stock at $8.00 per share (Press release, Monopar Therapeutics, DEC 18, 2019, View Source [SID1234552492]). The shares are expected to begin trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR." The offering is expected to close on December 23, 2019, subject to the satisfaction of customary closing conditions. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 166,666 shares.

JonesTrading Institutional Services LLC acted as Lead Bookrunning Manager and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as Co-Manager for the offering.

The offering of these securities will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these shares in any state in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any state.