On January 16, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported an agenda for the investor conference call to be presented today, Wednesday January 16, at 4:00 p.m. Eastern time (Press release, Generex, JAN 16, 2019, View Source [SID1234532682]). Joseph Moscato, Chief Executive Officer of Generex will outline the company’s strategic and financial plans, including details on financing transactions pertaining to the previously reported acquisitions of the Veneto Group assets and Olaregen. Additionally, Mr. Moscato will review the recent anticipated acquisitions of several profitable and innovative companies in the medical and surgical supply business, which include Pantheon Medical, MediSource, and most recently, Fuse Medical, a publicly traded company with nearly $30 million in projected annual revenues. In addition, Generex has signed a letter of intent for $15 million equity line of credit on more favorable terms than the equity line of credit previously reported.

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Importantly, tomorrow, January 17, 2019 (the report date), Generex will declare a dividend in the company’s wholly-owned subsidiary, NuGenerex Immuno-Oncology (formerly Antigen Express). The dividend will be structured such that for every 4 shares of Generex stock held on February 25, 2019 (the projected dividend payment date), investors will receive 1 share of NuGenerex Immuno-Oncology. Immediately following the dividend payout, Generex plans to list NuGenerex Immuno-Oncology on a public exchange. Additional details on this dividend will be provided on the conference call and in subsequent announcements.

"Generex is advancing our strategic initiatives to build value for our investors," stated Mr. Moscato. "And we are very happy to announce that Generex has signed a Letter of Intent to acquire Fuse Medical, subject to completed due diligence. The transaction has been structured as an all-stock deal valued at $34 million of Generex common stock at $2.50 per share with the potential for earnouts based on certain performance in 2019. The deal is not dilutive to our shareholders, as the payment is being made from the Generex pool shares that are described in the December 4, 2018 8K filing. Fuse is a publicly-traded surgical supply company with revenues approaching $30 million and EBITDA of approximately $5 million. The company distributes a broad portfolio of specialty surgical products to healthcare providers nationwide, bringing not only sales and distribution channels, but also a network of customers that will advance the Generex mission to deliver innovative end-to-end solutions to our healthcare partners, physicians, and patients. I will provide details on these potential acquisitions as well as on our plan to further expand the company’s footprint through the acquisition of a health system management company with a network of 13 hospitals in several states."

Mr. Moscato continued, "I am also pleased to announce that we have been able to restructure our $35 million debt obligation in a timely manner with the Veneto Group partners, through an agreement on the payment of $15.75 million in Generex common stock at the up-market price of $2.50 per share, that satisfies a significant portion of the $35 million obligation, plus $20 million in cash or stock to follow within 90 Days. The payment to the Veneto Group partners is being made with already accounted for shares in the Generex pool (See 8K on 12/4/18), which is non-dilutive to our current shareholders, as the total number of outstanding shares and capital structure remain the same. Additional information will be discussed at the conference call, followed by an 8k filing. The stock transaction demonstrates the Veneto Groups confidence in our strategic growth plan, because the deal is at a significant premium to our current market valuation. In addition to the Veneto deal, we have agreed to increase the Generex ownership of Olaregen Therapeutix, our regenerative medicine subsidiary, from 51% to approximately 72% through an agreement to acquire all of Olaragen’s outstanding Series A Preferred Stock in exchange for Generex stock and a second payment of either stock or cash. Again, these stock transactions are non-dilutive to our current shareholders, and reserve cash for advancing the company’s strategic plans. Further, we are in discussions with the remaining Olaregen shareholders to acquire up to 100% of the company."

Lastly, by the end of the month, Generex expects to receive the final audit report on the direct to patient pharmacy network, which the company had previously announced in a letter of intent to acquire the network of pharmacies and IT systems. The audit report will enable Generex to finalize the terms and price of the acquisition, thereby providing a path toward integration of the pharmacy network into NuGenerex Distribution Solutions in the near future. "We’re excited about the opportunity to potentially expand our pharmacy network that ultimately will enhance our distribution and direct to patient capabilities. We look forward to integrating the pharmacy’s cutting edge database systems and operational capabilities to grow our Distribution Solutions business with by introducing a number of innovative pharmacy programs," stated Terry Thompson, COO of Generex and President of NuGenerex Distribution Solutions.

On the conference call, Mr. Moscato will provide more in depth details on the Company’s financing initiatives, an overview of the recent potential acquisitions in the medical & surgical supply business, an update on the impending commercial launch of Olaregen’s wound healing product Excellagen, and a review of the pending acquisition of the pharmacy network, IT systems, and direct to patient databases. Mr. Moscato will also provide information regarding the dividend and spin out of NuGenerex Immuno-Oncology, and will wrap up the call with an update on the plan for up-listing Generex to a major stock exchange. Generex will be filing 8Ks with the SEC covering the information shared on the conference call and in corporate communications.

Mr. Moscato concluded, "As always, we will leave sufficient time at the end of call to address any and all questions from our loyal Generex shareholders, and I look forward to an informative discussion on Wednesday afternoon."

The access information for the investor conference call is as follows:

Wednesday January 16, at 4:00 p.m. Eastern time

Domestic US/Canada – 1-(866) 342-8588

Direct Toll / International – 1-(203) 518-9865

Conference ID – 85014

On January 16, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it intends to offer and sell, subject to market and other conditions, $75.0 million of shares of its common stock in an underwritten public offering (Press release, Mirati, JAN 16, 2019, View Source [SID1234532703]). Mirati expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares are being offered by Mirati. 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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J.P. Morgan Securities LLC, Citigroup Global Markets Inc., Cowen and Company, LLC, Barclays Capital Inc. and Credit Suisse Securities (USA) LLC are acting as joint book-running managers in the offering.

The securities described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. 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 View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

This press release shall 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 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 January 16, 2019 Nexus Pharmaceuticals Inc. reported the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company’s AP-rated therapeutic equivalent for Busulfex 60 mg/10 mL (6 mg/1 mL) (Press release, Nexus Pharma, JAN 16, 2019, View Source [SID1234532683]).

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"The FDA approval of Busulfan continues to expand our portfolio of difficult to manufacture injectables, in addition to becoming our second oncology generic drug," said Omair Ahmed, Chief Commercial Officer, Nexus Pharmaceuticals. "Busulfan is currently on American Society of Health System Pharmacists drug shortage list. The addition of Busulfan will continue to show our commitment to providing patients and clinicians with access to affordable generic alternatives to critical need medicines that have a history of shortage."

Busulfan is expected to launch in the United States shortly in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 mL of clear sterile solution. It is Latex and Preservative free.

About Busulfan Injection

Busulfan is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.

On January 16, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-601 in patients with selected solid tumors that are locally advanced or metastatic (Press release, ADC Therapeutics, JAN 16, 2019, View Source [SID1234596066]).

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ADCT-601 is an ADC composed of a humanized monoclonal antibody against human AXL, conjugated using GlycoConnect site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "AXL is a novel and ideal target for an ADC approach, as it is overexpressed in many solid tumor types. We look forward to exploring the effect of ADCT-601 on patients with selected advanced solid tumors who have failed or are intolerant to any established therapy. With five ADCs in eight ongoing clinical trials for multiple indications, we believe our highly targeted therapies have the potential to meaningfully improve outcomes for patients with solid tumors and hematological cancers."

The open-label, multicenter, single-arm trial will include a Phase Ia dose-escalation part followed by a Phase Ib dose-expansion part. The dose-escalation part is designed to determine the maximum tolerated dose of ADCT-601. The identified dose will be evaluated in the dose-expansion part. Approximately 75 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03700294).

About ADCT-601

ADCT-601 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human AXL, conjugated using GlycoConnect technology to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to an AXL-expressing cell, ADCT-601 is internalized into the cell where enzymes release the PBD-based warhead. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and ultimately killing the cancer cell. ADCT-601 is being evaluated in a Phase I clinical trial in patients with advanced solid tumors (NCT03700294).

On January 16, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that the Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer (Press release, Qiagen, JAN 16, 2019, View Source [SID1234532684]). The therascreen EGFR RGQ PCR Kit is registered in more than 40 countries globally. This marks the first companion diagnostic approval for QIAGEN in Japan.

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"As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics for QIAGEN. "In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments."

QIAGEN is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development and has been the market leader in companion diagnostics working under master collaboration agreements with more than 25 pharmaceutical companies developing companion diagnostic tests for their drug candidates. For more details surrounding QIAGEN’s companion diagnostics and their claims please visit www.qiagen.com. For additional information on Pfizer’s VIZIMPRO (dacomitinib) please visit www.pfizer.com.