Athenex Announces $60 Million Private Placement

On December 5, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has directly entered into an agreement for the sale of its common stock in a private placement with a group of institutional investors (Press release, Athenex, DEC 5, 2019, View Source [SID1234551959]). The lead investor in the private placement is Kingdon Capital Management, LLC. The transaction is expected to result in gross proceeds to Athenex of approximately $60 million, before deducting offering expenses. Net proceeds from the transaction are expected to be used to fund clinical development and regulatory activities for oral paclitaxel and encequidar; regulatory activities for tirbanibulin ointment for the treatment of actinic keratosis; commercialization activities, including pre-launch activities for oral paclitaxel and encequidar; manufacturing infrastructure; and working capital and general corporate purposes.

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The Company will issue 3,945,750 shares of common stock for a purchase price of $15.30 per share, for aggregate gross proceeds of approximately $60 million. The closing of the private placement is expected to occur on or about December 9, 2019, subject to customary closing conditions.

SunTrust Robinson Humphrey has acted as an exclusive placement agent to the Company in this private placement.

The offering of shares of common stock has not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and the shares are being offered pursuant to an exemption from the registration requirements of the Securities Act and similar exemptions under applicable state securities laws. At the closing of the offering, the Company will enter into a registration rights agreement with the investors, pursuant to which the Company will agree to file a registration statement with the Securities and Exchange Commission registering for resale the shares issued in this private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or 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.

Applied DNA Schedules Fiscal 2019 Fourth Quarter Financial Results Conference Call for Thursday, December 12, 2019 at 4:30 PM ET

On December 5, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN), reported it plans to release financial results for its fiscal 2019 fourth quarter ended September 30, 2019 after market close on Thursday, December 12, 2019 (Press release, Applied DNA Sciences, DEC 5, 2019, View Source [SID1234551955]). In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

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What: Applied DNA’s Fiscal 2019 Fourth Quarter Financial Results Conference Call
When: Thursday, December 12, 2019, at 4:30 p.m. Eastern Time
Where: Via phone by dialing +1 844-887-9402 or +1 412-317-6798 and ask to join the Applied DNA call; via webcast.

A telephonic replay of the conference call will be available for one day and may be accessed by calling +1 877-344-7529 or +1 412-317-0088 with the passcode 10136194. The webcast will be archived within the ‘Events and Presentations’ portion of the ‘Investors’ page to the company’s website.

Novartis tender offer for The Medicines Company commences

On December 5, 2019 Novartis AG (NYSE: NVS) ("Novartis") reported that its indirect wholly-owned subsidiary, Medusa Merger Corporation, a Delaware corporation ("Purchaser"), has commenced a cash tender offer to purchase all of the outstanding shares of common stock, par value USD 0.001 per share, of The Medicines Company (NASDAQ: MDCO) for a price of USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding (the "Offer") (Press release, Novartis, DEC 5, 2019, View Source [SID1234551952]). The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase, dated December 5, 2019, and the related Letter of Transmittal and pursuant to the terms of the previously announced Agreement and Plan of Merger, dated as of November 23, 2019 (the "Merger Agreement"), among Novartis, Purchaser and The Medicines Company.

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The Offer will expire at 12:00 midnight, New York City time, at the end of the day on January 3, 2020, unless extended (the latest time and date at which the Offer will expire, the "Expiration Date"). Any extension of the Offer will be followed by public announcement of the extension by press release or other public announcement before 9:00 a.m., New York City time, on the next business day after the Expiration Date.

Novartis will file today a Tender Offer Statement on Schedule TO with the United States Securities and Exchange Commission (the "SEC"). The Offer to Purchase contained within the Schedule TO sets out the full terms and conditions of the Offer.

The Medicines Company will file today a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, which includes, among other things, the recommendation of The Medicines Company board of directors that The Medicines Company’s stockholders accept the Offer and tender their shares of The Medicines Company common stock pursuant to the Offer.

The Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of The Medicines Company common stock and the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The Offer is subject to other important conditions set forth in the Offer to Purchase. The Offer is not subject to a financing condition.

Innisfree M&A Incorporated is acting as information agent for Purchaser in the Offer. American Stock Transfer & Trust Company, LLC is acting as the depositary and paying agent in the Offer. Requests for documents and questions by stockholders relating to the Offer may be directed to Innisfree M&A Incorporated by telephone at 1 (888) 750-5834 (toll free).

Genmab Achieves USD 100 Million Sales Milestone in DARZALEX® (daratumumab) Collaboration with Janssen

On December 5, 2019 Genmab A/S (Nasdaq: GMAB) reported that it has achieved a USD 100 million sales volume milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc (Press release, Genmab, DEC 5, 2019, View Source [SID1234551951]). The milestone was triggered by confirmation from Janssen that sales of DARZALEX reached USD 2.5 billion in a calendar year. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

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"We remain very pleased with the robust uptake seen with DARZALEX since its initial launch and with new approvals this year and potential approvals in 2020, we hope that it becomes even more widely available for the many multiple myeloma patients in need," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The milestone was included in the original financial guidance issued by Genmab on February 20, 2019, and in the improved financial guidance issued on November 6, 2019, as such there is no change to the company’s financial guidance for 2019.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

BioHybrid Solutions Awarded $30M Contract by the US Dept. of Defense

On December 4, 2019 BioHybrid Solutions, LLC (BHS), a Pittsburgh-based protein engineering company, reported that it was awarded a contract worth up to $30 million from the United States Department of Defense to develop a next-generation prophylactic medical countermeasure (Press release, Myris Therapeutics, DEC 4, 2019, View Source [SID1234650500]). The project was sponsored by the U.S. Government through the Medical CBRN Defense Consortium (MCDC).

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The U.S. Defense Threat Reduction Agency (DTRA) selected BHS through a request for prototype proposal under the MCDC to apply its proprietary NanoArmored protein engineering technology to improve pharmacokinetics of the prophylactic while reducing the potential for immunogenic side effects. Over the five-year program, BHS will develop NanoArmored drug candidates, conduct studies to demonstrate functionality, scale manufacturing, and complete regulatory activities towards approval of the countermeasure by the U.S. Food and Drug Administration (FDA). BHS is leading the program in collaboration with FLIR Systems, Battelle, Ology Bioservices, the Allegheny Health Network, BTG PLC (now part of Boston Scientific) and the US Army.

"We have developed a unique way to protect against the toxic effects of chemical warfare agents and are honored to have been selected by DTRA to lead this very important program," said Alan Russell, Co-Founder and CEO of BioHybrid Solutions.

In order to expedite development, BHS will utilize its specialized high-throughput discovery technology to rapidly select the NanoArmor needed and then manufacture that drug candidate. "Our technology allows us to rationally tune protein performance through precision modification of proteins with a wide variety of synthetic polymers," noted Krzysztof Matyjaszewski, BHS Co-Founder and CSO. "To date, we have created thousands of different NanoArmored proteins for a variety of industrial and therapeutic indications. We are well positioned to apply our technology to this important national security and public health application."