Ascendis Pharma A/S Announces Second Quarter 2021 Financial Results and Business Update Conference Call on August 25

On August 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will hold a conference call and live webcast on Wednesday, August 25, 2021 at 4:30 p.m. Eastern Time (ET) to review its second quarter 2021 financial results and provide a business update (Press release, Ascendis Pharma, AUG 17, 2021, View Source [SID1234586693]).

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A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

PROMIS NEUROSCIENCES INC. ANNOUNCES US$15 MILLION OFFERING OF UNITS

On August 17, 2021 ProMIS Neurosciences Inc. ("ProMIS" or the "Company") (TSX: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that it has filed today a preliminary prospectus supplement (the "Supplement") to its final short form base shelf prospectus dated June 30, 2021 (the "Base Prospectus") in connection with a proposed commercially reasonable efforts public offering of units (the "Units") for gross proceeds to the Company of up to US$15,000,000, exclusive of the Agent’s Option (as defined herein) (the "Offering") (Press release, ProMIS Neurosciences, AUG 17, 2021, View Source [SID1234586691]).

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Each Unit consists of one common share of the Company (a "Common Share") and one quarter of one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share (each, a "Warrant Share") at any time up to 60 months following Closing (as defined below), subject to an acceleration provision such that in the event that following the Closing the Common Shares have a volume weighted average price on the Toronto Stock Exchange ("TSX") greater than three (3) times the Warrant exercise price for each of ten (10) consecutive trading days (based on the Bank of Canada noon exchange rate on the applicable trading day), then the Company may accelerate the expiry date of the Warrants to a date that is 30 days after the date on which the Company gives notice of the acceleration to the holders of Warrants.. The Units offered under the Offering will be priced in the context of the market and pricing will be reflected in a final prospectus supplement.

The Supplement was filed with the securities regulatory authorities in each of the province and territories of Canada (other than Québec). Additionally, the Offering is expected to be conducted by way of private placement other jurisdictions where the Offering can lawfully be made.

In connection with the Offering, the Company intends to enter into an agency agreement with Leede Jones Gable Inc. (the "Agent") and certain other agents to be added to the syndicate. The Company expects to close the Offering on or about August 24, 2021, or other such date as may be mutually agreed to by the Company and the Agent (the "Closing"), subject to satisfaction of customary closing conditions, including the approval of the listing of the Common Shares and the Warrant Shares on the TSX.

The Company has agreed to grant to the Agent an option (the "Agent’s Option"), exercisable, in whole or in part, at the sole discretion of the Agent, to increase the size of the Offering by up to 15%. The Agent’s Option is exercisable, in whole or in part, at any time until the date that is two (2) business days prior to the date of Closing.

The Company intends to use the net proceeds from the Offering to advance its lead Alzheimer’s therapy PMN310 to the filing of an Investigational New Drug ("IND") application to enable a first clinical trial, including working with a qualified vendor to manufacture drug product to GMP (Good Manufacturing Practice) standards, developing manufacturing assays as necessary for regulatory approvals, conducting animal toxicology studies to GLP (Good Laboratory Practice) standards at a qualified vendor, conducting additional in vivo testing of PMN310, and conducting formulation work with a qualified vendor to support potential development of a subcutaneous delivery form of PMN310, expanding the ProMIS portfolio of antibodies and patents, including further development of targets that have been disclosed (such as tau in Alzheimer’s disease, or RACK1 in amyotrophic lateral sclerosis (ALS), as well as addressing novel mis-folded protein targets implicated in disease with the ProMIS technology platform and general corporate purposes. Any additional proceeds from the Offering, such as those from the possible exercise of the Agent’s Option will be used to: (a) conduct activities that might speed the progress to file an IND and, subject to the U.S. Federal Drug Administration’s approval, to commence a clinical trial for PMN310; (b) accelerate other research and development programs with additional in vitro and in vivo work; (c) increase the rate of hiring additional key personnel in critical areas such as Clinical Operations and Discovery Operations; and/or (d) increase expenditures on shareholder and investor relations.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and such securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from such registration requirements. This press release does not constitute an offer for sale of securities nor a solicitation for offers to buy any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Carrick Therapeutics to Present First Clinical Data on Samuraciclib (CT-7001), a First-In-Class Inhibitor of CDK7 at the European Society for Medical Oncology (ESMO) Congress 2021

On August 17, 2021 Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, reported two presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, to be held from September 16-21, 2021 (Press release, Carrick Therapeutics, AUG 17, 2021, View Source [SID1234586690]). An e-poster will be available from 07:30 BST (02:30am ET) on September 16, 2021, and a mini-oral presentation from 17:10 BST (12:10pm ET) on September 18, 2021.

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Poster and oral presentation details are as follows:

Poster Presentation Title: Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+ BC)
Presenting Author: Sacha Howell, The Christie NHS Foundation Trust Manchester, UK
Abstract number: 1346 (265P)

Oral Presentation Title: First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies
Presenting Author: Matthew G. Krebs, The Christie NHS Foundation Trust & University of Manchester, UK
Abstract number: 943 (230MO)

About Samuraciclib (CT7001)
Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. It is currently being evaluated in Phase 2a studies targeting CDK4/6 inhibitor resistant second-line HR+, HER2- metastatic breast cancer, in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer and in combination with chemotherapy for the treatment of locally advanced or metastatic TNBC.

Navrogen Inc. and Tavotek Biotherapeutics Announce Strategic Collaboration to Improve Therapeutic Efficacy of Antibody Pipeline Agents

On August 17, 2021 Navrogen Inc. ("Navrogen"), a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and Tavotek Biotherapeutics ("Tavotek"), a biotech company focusing on novel multi-specific antibodies in immuno-oncology and autoimmune diseases, reported that they have entered into a strategic collaboration to identify and develop experimental monoclonal antibodies (mAbs) for the treatment of various cancer indications (Press release, Navrogen, AUG 17, 2021, View Source [SID1234586689]).

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Under the agreement, Navrogen and Tavotek will collaborate on the development of future Tavotek oncology assets while utilizing Navrogen’s proprietary screening technology to identify mAb leads that are susceptible to Humoral Immuno-Oncology (HIO) factors. HIO is a process by which tumors produce factors that suppress a patient’s humoral immune response against malignant tissues as well as diminish therapeutic response of immune-mediated anti-cancer therapies. Working with Navrogen’s HIO platform technologies and its expertise in patient tumor screening methods, the teams will identify and/or engineer HIO-refractory antibodies that are effective across a wide range of HIO-positive cancers leading to innovative treatment options for patients with limited therapeutic options.

Epigenomics AG: Execution of a Biobank Sale Agreement and Update of Guidance

On August 17, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has entered into an agreement with New Horizon Health Limited (6606.HK) on the sale of certain non-essential biological samples. Gross proceeds from the sale are USD 6.7 million from which Epigenomics receives USD 4.7 million at closing and the remainder is payable within 90 days based upon the Company providing verification of sample integrity and documentation. The Company is retaining all necessary samples for the on-going development of Epi proColon Next-Gen and other R&D activities. As a result of the sale, the Company is updating its current full year 2021 revenue and earnings guidance to approximately EUR 6.0 million of revenue and EUR -3.0 million to EUR -4.0 million of EBITDA before share-based payment expenses. Cash consumption in 2021 is expected to be between EUR 3.5 million and EUR 4.5 million.

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