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Generex Biotechnology Announces Investor Conference Call; Management to Provide Update on Acquisitions, Financing Initiatives & Strategic Plans

On January 10, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) reported that it will hold an investor conference call on Wednesday, January 16th, at 4:00 p.m. to update investors on the previously announced and pending acquisitions that offer significant value to the Generex parent company (Press release, Generex, JAN 10, 2019, View Source [SID1234532615]). Joseph Moscato, Generex President & Chief Executive Officer, will discuss the company’s financing plans related to the acquisitions, as well as the strategic focus of Generex for 2019 and beyond. Additionally, Mr. Moscato will provide guidance on the recent merger of Antigen Express into the newly-formed NuGenerex Immuno-oncology, and the proposed spin-out of the company as an independent, public company with a new direction and strategic focus to advance the Ii-Key technology for the immunotherapy of cancer, which includes plans for a rights offering and stock dividend for Generex shareholders in NuGenerex Immuno-Oncology. Further, Mr. Moscato will discuss plans to up-list Generex to a major stock exchange.

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Mr. Moscato stated, "We have worked diligently over the last several years to transform Generex into an integrated healthcare holding company. In the last two years, we have completed a complex reorganization plan, and we continue to execute on the strategic acquisition of several exciting companies with revenues, products, and new technologies.

"We are in the early stages of our plan that has begun with acquisitions of an MSO network of physicians and surgeons, pharmacies, a laboratory, a surgical supply business, a manufacturer of surgical implants, and two regenerative medicine companies, Regentys and Olaregen. These and future acquisitions will enable Generex to grow through generating significant product and service revenues, while creating exponential value for our shareholders through development of our deep pipeline of clinical-stage assets. I look forward to addressing my fellow Generex shareholders to provide details about recent and pending acquisitions, our growth strategies for NuGenerex Distribution Solutions, and the launch of Generex’s first commercial product Excellagen. I will also discuss the strategy to spin out NuGenerex Immuno-Oncology as an independent public company, with an update on the plan for up-listing Generex."

Dial-in instructions for the investor conference call will be announced on Monday, January 14, 2019.

Heat Biologics Provides Clinical and Business Update

On January 10, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported a business update regarding the company’s progress and plans for 2019 (Press release, Heat Biologics, JAN 10, 2019, View Source [SID1234532613]).

Key highlights:

Phase 2 trial expanded to evaluate the benefit of HS-110 in combination with a different anti-PD-1 checkpoint inhibitor to treat patients earlier in the course of their metastatic disease
Selected to deliver podium presentation of interim Phase 2 lung cancer data at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28, 2019
Remains on track to complete enrollment of Phase 2 lung cancer trial in Q2, 2019
Strong balance sheet entering 2019
Jeff Wolf, Heat’s CEO, commented, "We have postponed reporting our most recent interim data to enable us to present this data at a leading oncology conference. We are honored that our lead investigator, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, has been selected to deliver an oral presentation of this data at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28."

Mr. Wolf continued, "We continue to make rapid progress on our Phase 2 trial and remain on track to complete enrollment in this trial in Q2, 2019. The resources provided by our recent funding have enabled us to explore a variety of options to expand the current trial to evaluate the benefit of HS-110 in combination with a different anti-PD-1 checkpoint inhibitor to treat patients earlier in the course of their metastatic disease. The details of this expansion will be announced shortly."

"Our balance sheet is strong as we head into the new year. We recently completed a capital raise of $13.8 million in addition to our cash balance of $21.0 million at the end of the third quarter of 2018. We also expect to receive an additional $6.9 million in CPRIT grant funds later this year. The strength of our balance sheet provides us much greater flexibility to expand our lead Phase 2 trial, accelerate our internal programs and explore complementary opportunities within the lung cancer market and beyond."

Cancer Genetics, Inc. Announces Proposed Public Offering of Common Stock

On January 9, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, BioServe Biotechnologies, JAN 9, 2019, View Source [SID1234532594]). Cancer Genetics also expects to grant the underwriter a 45-day option to purchase additional shares of its common stock to cover over-allotments, if any. 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.

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

Cancer Genetics intends to use the net proceeds from this offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements we are negotiating with our banks, to pay certain costs previously incurred by us in connection with our terminated transaction with NovellusDx Ltd., and if any proceeds remain available, to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, 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 The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 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 any such 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

Entry into a Material Definitive Agreement.

On January 9, 2019 Puma Biotechnology, Inc. (the "Company") reported that it has entered into a License Agreement (the "Agreement") with Knight Therapeutics Inc. ("Knight") (Filing, 8-K, Puma Biotechnology, JAN 9, 2019, View Source [SID1234532676]).

Pursuant to the Agreement, the Company granted to Knight, under certain of the Company’s intellectual property rights relating to neratinib, an exclusive, sublicensable (under certain circumstances) license (i) to commercialize any product containing neratinib and certain related compounds (the "Licensed Product") in Canada (the "Territory"), (ii) to seek and maintain regulatory approvals for the Licensed Products in the Territory and (iii) to manufacture the Licensed Products anywhere in the world solely for the development and commercialization of the Licensed Products in the Territory for human use, subject to the terms of the Agreement and a supply agreement to be negotiated and executed by the parties.

Under the terms of the Agreement, the Company will be solely responsible for the manufacturing and supply of the Licensed Products to Knight, but under limited circumstances Knight may obtain the right to manufacture the Licensed Products under the supply agreement.

The Agreement sets forth the parties’ respective obligations with respect to the commercialization of the Licensed Products. Within the Territory, the Company will be solely responsible for obtaining the regulatory approval for the indication of extended adjuvant treatment of HER2-positive early stage breast cancer ("Initial Indication") and Knight will use commercially reasonable efforts to prepare, file and manage regulatory filings for any other indications in the field of human use. Promptly after obtaining the regulatory approval for the Initial Indication in the Territory, the Company will transfer such regulatory approval to Knight, and Knight will own and hold any regulatory approvals for the Licensed Products in the Territory in its name.

Pursuant to the Agreement, the Company is entitled to upfront and development milestones of up to US$2.0 million, and sales milestone payments of up to CAN$7.0 million, payable upon achievement of the milestone events specified in the Agreement. Furthermore, the Company is entitled to receive significant double digit royalties calculated as a percentage of net sales of the Licensed Products in the Territory.

The term of the Agreement continues, on a Licensed Product-by-Licensed Product basis, until the later of (i) the expiration or abandonment of the last valid claim of the licensed patents that covers such Licensed Product in the Territory, or (ii) the earlier of (x) the time when generic competitors to such Licensed Product have achieved seventy percent (70%) or more market share in the Territory based on unit volume, or (y) ten (10) years following the date of first commercial sale of such Licensed Product in the Territory. The Agreement may be terminated by either party if the other party commits a material breach, subject to a customary cure period, or if the other party is insolvent. Knight may terminate the agreement with ninety (90) days’ written notice in the event either party or both parties receive any written claim alleging that the manufacture or commercialization of the Licensed Products in the Territory infringes, misappropriates, or otherwise violates any intellectual property rights of a third party. The foregoing description of the Agreement is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019.

BerGenBio Announces Start of Phase I Trial Evaluating First-in-Class Anti-AXL Antibody BGB149

On January 9, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class drug candidates targeting AXL kinase to treat aggressive diseases including immune-evasive and therapy resistant cancers, reported that the first subject has been dosed in a Phase I clinical trial evaluating the anti-AXL therapeutic monoclonal antibody BGB149 in healthy volunteers (Press release, BerGenBio, JAN 9, 2019, View Source [SID1234532614]).

BGB149 is the first functional blocking anti-AXL monoclonal antibody to enter clinical development and is BerGenBio’s second clinical stage drug development programme targeting AXL.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are delighted to initiate this Phase I study as planned. BGB149 has cleared all required regulatory pre-clinical evaluations. This AXL functional blocking antibody is BerGenBio’s second drug candidate to enter clinical trials: An important milestone in expanding our pipeline of first-in-class AXL targeting drug candidates positioned to treat aggressive diseases with severe unmet medical need. We are expecting results from this Phase I trial in 2019 and are looking forward to announcing BGB149’s further clinical development strategy in the coming months."

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About BGB149 and the Phase I Healthy Volunteer Trial
BGB149 is a fully humanised anti-AXL functional blocking monoclonal antibody, developed and fully-owned by BerGenBio. A robust, high yielding manufacturing process has been established and preclinical studies have confirmed its mechanism of action as well as efficacy.

The Phase I healthy volunteer trial BGB149-101 will enrol up to 36 subjects andinvestigate the safety, tolerability and pharmacokinetics of BGB149 following single dose administration.The study is being sponsored by BerGenBio.

For more information, see ClinicalTrials.gov: NCT03795142

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that Axl mediates other aggressive diseases